COVID-19: Key Food, Drug and Medical Device Regulatory Updates

Week of February 8

• FDA published a letter to health care providers regarding the use of “ventilator splitters” during the COVID-19 pandemic.
• FDA updated three guidance documents regarding alcohol-based hand sanitizer products during the COVID-19 pandemic: (1) Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products; (2) Temporary Policy for Manufacture of Alcohol for Incorporation into Alcohol-Based Hand Sanitizer Products; (3) Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products. The policies were last updated in August 2020.
• FDA updated its guidance on investigational COVID-19 convalescent plasma. 

Week of February 1

• FDA updated its guidance on manufacturing, supply chain, and drug and biological product inspections during the COVID-19 pandemic.
• FDA announced that the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will convene to consider the Emergency Use Authorization (EUA) for a third COVID-19 vaccine candidate on February 26th. Background materials for the meeting will be made available to the public no later than two business days before the meeting.
• Acting FDA Commissioner Janet Woodcock published a statement regarding FDA’s work to support medical product development to address new Coronavirus variants. 

Week of January 25

• FDA updated its guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic.
• FDA revised its enforcement policy for coagulation systems for measurement of viscoelastic properties during the COVID-19 public health emergency. 

Week of January 18, 2021

• FDA published guidance on protecting participants in bioequivalence studies for Abbreviated New Drug Applications (ANDAs) during the COVID-19 pandemic.
• FDA updated its guidance on investigational COVID-19 convalescent plasma.
• FDA published guidance on manufacturing considerations for licensed and investigational cellular and gene therapy products during the COVID-19 pandemic. 
• FDA published guidance for the testing of alcohol (ethanol) and isopropyl alcohol for methanol, including during the COVID-19 pandemic.
• FDA entered into a Memorandum of Understanding (MOU) with the National Institute of Standards and Technology at the U.S. Department of Commerce. The MOU is intended to increase U.S. medical supply chain resilience and advance domestic manufacturing of pharmaceuticals, biopharmaceuticals, and medical devices through adoption of 21st century manufacturing technologies including smart technologies, emerging manufacturing processes, and artificial intelligence and machine learning.
• President Biden signed several new Executive Orders aimed to speed up production of COVID-19 supplies, increase testing capacity, and require masks during interstate travel. One of the President’s Executive Orders invokes the use of the Defense Production Act to increase manufacturing of vaccines, personal protective equipment (PPE), and other supplies vital for the pandemic response. See https://www.whitehouse.gov/wp-content/uploads/2021/01/National-Strategy-for-the-COVID-19-Response-and-Pandemic-Preparedness.pdf.

Week of January 11, 2021

• Secretary of Health and Human Services Alex Azar renewed the determination that a public health emergency exists as a result of COVID-19. The first declaration was made on January 27, 2020.
• HHS published a notice in the Federal Register “to permanently exempt or proposing to permanently exempt certain class I and class II medical devices from the premarket notification requirement.” Under the Notice, HHS permanently exempted seven class I devices and is proposing to exempt 84 class II devices, including seven types of surgical and examination gloves, certain sterilizers, face masks, and ventilators, from premarket review. Permanently exempted medical devices will no longer require FDA premarket review under section 510(k) of the federal Food, Drug, and Cosmetic Act.
• FDA issued an Emergency Use Authorization for the first serology test that uses fingerstick whole blood to detect Coronavirus antibodies.
• FDA issued a guidance document on COVID-19 potency assay considerations for monoclonal antibodies and other therapeutic proteins targeting SARS-CoV-2 infectivity.
• FDA issued a guidance document regarding coagulation systems for the measurement of viscoelastic properties.
• The New York Times reported that President-Elect Biden has picked former FDA Commissioner David Kessler, M.D. to lead the Biden Administration’s Operation Warp Speed.

Week of December 28, 2020

• FDA published a Guidance on review timelines for applicant responses to Complete Response Letters when a facility assessment is needed during the COVID-19 public health emergency.
• FDA updated its Guidance on the effects of the COVID-19 pandemic on formal meetings and user fee applications for medical devices.
• FDA authorized the emergency use of SCONE negative pressure enclosure. The device is authorized for use by healthcare providers as an extra layers of barrier protection in addition to personal protective equipment to prevent exposure to airborne pathogens such as COVID-19.
• FDA published an infographic showing the number of FDA-authorized COVID-19 tests and collection kits.

Week of December 14, 2020

• FDA issued a new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. FDA press release here.
• FDA authorized the emergency use of the first over-the-counter fully at-home COVID-19 diagnostic test. FDA press release here.
• The U.S. Attorney’s Office for the Southern District of California announced the indictment of a San Diego physician for allegedly selling COVID-19 “treatment kits,” including hydroxychloroquine.

Week of December 7, 2020

• FDA authorized the emergency use of the first direct-to-consumer COVID-19 test system. FDA press release here.
• FDA authorized the emergency use of the first ultraviolet-C (UV-C) light-based bioburden reduction system. The system helps to reduce bioburden of certain N95 respirators when there are insufficient supplies resulting from the COVID-19 pandemic.
• FDA updated its guidance on the conduct of clinical trials of medical products during the COVID-19 public health emergency.
• FDA published an enforcement policy for the quality standards of the Mammography Quality Standards Act during the COVID-19 public health emergency.

Week of November 30, 2020

• FDA authorized the emergency use of another monoclonal antibody cocktail for the treatment of COVID-19. FDA press release here.
• FDA updated its webpages regarding vaccines, including adding a webpage on EUAs for Vaccines.
• FDA established a new webpage regarding face masks, including surgical masks and respirators for COVID-19. 
• FDA published an enforcement policy on the use of dry heat to support single-user reuse of certain particulate filtering face piece respirators, such as N95 respirators, during the COVID-19 pandemic. FDA press release here.
• FDA revised its guidance on notifying the Center for Devices and Radiological Health of a permanent discontinuance or interruption in manufacturing of a device under Food, Drug, and Cosmetic Act Section 506J during the COVID-19 pandemic. 
• FDA announced that a second meeting of the Vaccines and Related Biological Products Advisory Committee will take place on December 17th to discuss the request for Emergency Use Authorization for a COVID-19 vaccine candidate submitted by Moderna Inc.
• The Government Accountability Office published a report entitled “COVID-19-Urgent Actions Needed to Better Ensure an Effective Federal Response.”

November 19, 2020

• The Department of Health and Human Services launched a pilot program with five states to use portable, cartridge-based COVID-19 molecular test kits that provide rapid results. The states in the program are Florida, Louisiana, New Jersey, Texas, and Alaska.

November 17, 2020

• FDA updated its guidance on investigational COVID-19 convalescent plasma.
• FDA published a new webpage addressing COVID-19 diagnostic testing.

November 16, 2020

• At FDA’s request, the U.S. Department of Justice filed a civil complaint against Natural Solutions Foundation and two individuals associated with the entity to permanently enjoin them from distributing an allegedly fraudulent treatment for COVID-19.  FDA and FTC had previously issued a Warning Letter to the defendants.
• The National Institutes of Health and Moderna announced results from the Phase 3 clinical trial of Moderna’s COVID-19 vaccine candidate. NIH press release here.

November 13, 2020

• FDA updated the progress of its Coronavirus Treatment Acceleration Program (CTAP). 
• FDA published a consumer update regarding fraudulent flu products during the COVID-19 pandemic. 

November 12, 2020

• FDA Commissioner Stephen M. Hahn, M.D. provided an update on the Agency’s response to COVID-19 in remarks to a generics and biosimilar virtual conference. 

November 11, 2020

• The Centers for Disease Control and Prevention published a scientific brief, recommending the community use of cloth masks to prevent the transmission of the coronavirus.
• On November 12th from 12:00 pm – 1:00 pm (EST), FDA hosted a virtual presentation on the use of facial coverings during the COVID-19 pandemic.

November 10, 2020

• FDA authorized the emergency use of bamlanivimab, a monoclonal antibody therapy, for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients. FDA press release here.
• A National Institutes of Health (NIH) study concluded that hydroxychloroquine does not benefit adults hospitalized with COVID-19. 

November 9, 2020

• President-Elect Joseph Biden, Jr. announced the membership of his Coronavirus Task Force. The three co-chairs of the twelve-member panel are former Surgeon General Vivek H. Murthy, MD, former FDA Commissioner David A. Kessler, MD, and Yale University Professor Marcella Nunez-Smith, MD, MHS.
• FDA authorized the emergency use of the first serology test that detects neutralizing antibodies from recent or prior coronavirus infection. FDA press release here.

November 4, 2020

• FDA published a letter to clinical laboratory staff and healthcare providers regarding the potential for false positive results with antigen tests for the rapid detection of COVID-19.
• DA’s Center for Devices and Radiological Health also issued Warning Letters to two companies (antibody tests, rapid lateral flow tests), alleging the marketing of unauthorized COVID-19 tests.
• The Centers for Disease Control and Prevention published a request for information regarding the establishment of a centralized national reporting mechanism for COVID-19 laboratory test results and other reportable conditions.

November 3, 2020

• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA published a notice in the Federal Register requesting information about whether certain medical products held in the Strategic National Stockpile should be permitted to be labeled in a manner that does not comply with statutory and regulatory labeling requirements.
• Several individuals and non-profits from New York sued the Department of Health and Human Services and the Centers for Disease Control and Prevention, alleging a failure to prepare for or respond to the COVID-19 pandemic as required under the Pandemic and All-Hazards Preparedness Act and Advancing Innovation Act of 2019. 

November 2, 2020

• DA published a consumer update about at-home oxygen therapy.
• FDA, U.S. Customs and Border Protection and U.S. Immigration and Customs Enforcement Homeland Security Investigations (ICE-HSI) announced a Memorandum of Understanding to stop harmful and fraudulent products that pose a threat to public health from entering the U.S. though international mail facilities.
• FDA published a list of essential medicines, medical countermeasures, and critical inputs required by an August Executive Order.

October 29, 2020

• FDA revised its enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the COVID-19 pandemic. 
• FDA and FTC continue to issue Warning Letters (see dietary supplements, colloidal silver, and bee honey products) with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

October 28, 2020

• FDA Commissioner Stephen Hahn, M.D. made opening remarks at the Medical Device User Fee Act (MDUFA) Public Meeting. See Dr. Hahn’s speech here.
• Dr. Peter Marks, the Director of FDA’s Center for Biologics Evaluation and Research, published an opinion in USA Today regarding FDA’s evaluation of safety and efficacy with respect to COVID-19 vaccines. 

October 27, 2020

• FDA updated the template for COVID-19 antigen test developers. 
• FDA expanded an Emergency Use Authorization for a COVID-19 test, allowing, among other things, individual home collection of samples without healthcare professional supervision.

October 26, 2020

• FDA published a webpage on the development and manufacturing of drugs, including biologics. The webpage includes information on, e.g., the review process, good manufacturing practices, inspections, imports, and postmarket reporting.

October 23, 2020

• FDA approved the first therapeutic, remdesivir, to treat COVID-19. 

October 22, 2020

• FDA’s Vaccines and Related Biological Products Advisory Committee met on October 22nd to discuss the development and review of COVID-19 vaccines.  
• The Centers for Disease Control and Prevention updated its definition of  “close contact” with someone with COVID-19, for purposes of determining which individuals should get tested for the virus and/or self-quarantine. 
• The Department of Health and Human Services issued guidance for PREP Act coverage for qualified pharmacy technicians and state-authorized pharmacy interns for the administration of childhood vaccines, COVID-19 vaccines, and COVID-19 testing.

October 21, 2020

• In advance of FDA’s Vaccines and Related Biological Products Advisory Committee Meeting (FDA Vaccines AC Meeting) on October 22nd, the Agency posted several resources:
  • Peter Marks, M.D., PhD., Director of FDA’s Center for Biologics Evaluation and Research (CBER) joined Dr. Anand Shah, FDA’s Deputy Commissioner for Medical and Scientific Affairs, on the FDA Insight Podcast to discuss the FDA Vaccines AC meeting.
  • Dr. Peter Marks authored an article discussing this week’s FDA Vaccines AC Meeting.
  • FDA published a consumer update regarding the role of FDA Advisory Committees. 
• FDA authorized the emergency use of a new decontamination system for compatible N95 respirators for single-user reuse by healthcare personnel to prevent exposure to COVID-19 particulates when there are insufficient supplies of certain respirators as a result of the pandemic. 

October 20, 2020

• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• The Centers for Disease Control and Prevention issued an interim guidance recommending the wearing of face masks while on public conveyances and at stations, ports, and similar transportation hubs to prevent the spread of COVID-19.

October 16, 2020

• FDA amended two temporary policies on compounding during the COVID-19 pandemic to remove epinephrine from the lists of drugs for temporary compounding by outsourcing facilities and certain pharmacy compounders.

October 15, 2020

• FDA Commissioner Stephen M. Hahn, M.D. made remarks at the Reagan-Udall Foundation Annual Meeting, discussing, among other things, FDA’s Coronavirus response.

October 14, 2020

• FDA issued an enforcement policy for modifications to FDA-cleared molecular flu and respiratory syncytial virus (RSV) tests during the COVID-19 pandemic.

October 12, 2020

• Three FDA officials published an article in JAMA Oncology regarding FDA’s support for oncology drug development during the COVID-19 pandemic.

October 5, 2020

• FDA continues to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA Commissioner Stephen M. Hahn, M.D. gave a speech to the National Consumer League on the vaccine review process.
• The Department of Health and Human Services (HHS) will collaborate with the Rockefeller Foundation to identify and share effective approaches for using rapid point-of-care COVID-19 antigen tests to screen for COVID-19, with a focus on safely reopening schools.

October 1, 2020

• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• The National Institutes of Health awarded nearly $234 million to improve COVID-19 testing for underserved and vulnerable populations as part of its Rapid Acceleration of Diagnostics (RADx) initiative. 

September 30, 2020

• FDA Commissioner Stephen Hahn, M.D. published a statement regarding the Center of Devices and Radiological Health’s efforts in the COVID-19 response. 
• On September 30th, FDA’s Center for Devices and Radiological Health hosted its weekly Virtual Town Hall on COVID-19 diagnostic testing.

September 29, 2020

• The Department of Health and Human Services announced the national distribution plan for millions of rapid, point-of-care COVID-19 antigen tests to the States.  
• On September 29th from 12 pm – 1 pm (EST), FDA hosted a webinar on respirators and other personal protective equipment (PPE) for healthcare personnel use during the COVID-19 pandemic. 

September 28, 2020

• FDA authorized the emergency use of COVIAGE for use by healthcare providers as an extra layer of barrier protection in addition to personal protective equipment (PPE) to prevent exposure to COVID-19. COVIAGE is a negative pressure, clear tent enclosure which is attached to hospital beds and/or hospital stretchers.
• FDA issued an Emergency Use Authorization for a cloud-based software program used as a hemodynamic instability and respiratory decompensation system to be used by healthcare providers in the hospital setting for the computation of COVID-19 patient status indices. 

September 24, 2020

• FDA reissued an Emergency Use Authorization (EUA) for a point-of-care (POC) test for COVID-19. The reissued EUA authorizes the test for POC use using finger-stick blood samples. FDA press release here.
• FDA revoked its umbrella Emergency Use Authorization for infusion pumps and infusion pump accessories that was issued on May 13, 2020. FDA determined that individual EUAs would allow for tailored indications and scopes of authorization, such as for different environments, routes of administration, and patient populations. 
• The Department of Health and Human Services announced that the Centers for Disease Control and Prevention will provide $200 million to jurisdictions for COVID-19 vaccine preparedness. 

September 21, 2020

• Alex Azar, Secretary of the Department of Health and Human Services (HHS), issued a memorandum stating that all regulations issuing from any part of HHS must be signed by the Secretary. See HHS press release here.
• The Centers of Disease Control and Prevention (CDC) updated guidance on the spread of COVID-19. The CDC also updated its COVID-19 testing guidance.

September 16, 2020

• FDA and FTC continue to issue Warning Letters, see here and here, with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• The Senate Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a Hearing on September 16th at 10 a.m. (ET) on the Coronavirus Response Efforts. Robert Redfield, M.D., the Director of the Centers for Disease Control, Adm. Brett Giroir, M.D., the Assistant Secretary for Health at the Department of Health and Human Services, and Bob Kadlec, M.D., the Assistant Secretary for Preparedness and Response (ASPR) at the Department of Health and Human Services will testify.

September 15, 2020

• FDA issued guidance regarding assessing COVID-19-related symptoms in outpatient adult and adolescent participants in clinical trials of drugs and biological products for COVID-19 prevention or treatment.
• FDA awarded a research contract worth over $5 million to the University of Liverpool to analyze coronavirus clinical samples in an effort to better understand the evolution of the virus, characterize pathogen interactions and immunity and identify biomarkers of disease progression and severity.

September 14, 2020

• FDA Commissioner Stephen Hahn, M.D. and FDA Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D. published an article regarding FDA’s scientific and regulatory oversight of vaccines.
• On September 15th from 12:00 p.m.-1:00 p.m. (ET), FDA hosted a webinar on gowns and other apparel for use by healthcare personnel in the COVID-19 pandemic. Representatives from FDA, the Centers for Disease Control and Prevention and the Occupational Safety and Health Administration were available to answer questions.

September 11, 2020

• FDA published guidance regarding the resumption of normal drug and biologics manufacturing operations during the COVID-19 pandemic.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA Commissioner Stephen M. Hahn, MD  and Deputy Commissioner for Medical and Scientific Affairs Anand Shah, MD published an op-ed discussing how the COVID-19 pandemic underscores the need to bring back drug manufacturing to the United States.

September 10, 2020

• DA authorized the emergency use of a COVID-19 molecular diagnostic test indicated for, among other things, the testing of pooled samples of up to 12 individuals.
• FDA published a Consumer Update answering questions about nutrition as well as the safety and labeling of food, dietary supplements and cosmetics in light of COVID-19.
• The Director of FDA’s Center for Devices and Radiological Health (CDRH) Jeffrey Shuren, MD, JD and Timothy Stenzel, MD, PhD, the Director of CDRH’s Office of In Vitro Diagnostics, authored an opinion article describing the work the Agency has done to authorize COVID-19 tests.
• The Department of Health and Human Services published guidance for licensed pharmacists and pharmacy interns regarding COVID-19 vaccines and immunity under the PREP Act.

September 9, 2020

• FDA announced that it deactivated the FDA registration for 340 foreign establishments for failure to identify a U.S. Agent, as required by FDA regulations. FDA noted that 131 of these establishments list devices essential to the COVID-19 response.
• On September 10th, FDA hosted a webcast on advancing the science of real-world data to address the COVID-19 pandemic.

September 8, 2020

• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

September 3, 2020

• FDA updated its guidance regarding investigational COVID-19 convalescent plasma as well as the associated webpage.
• On September  9th, the Senate Committee on Health, Education, Labor and Pensions (HELP Committee) held a hearing on vaccine development. Francis Collins, M.D., PhD, Director of the National Institutes of Health (NIH) and Vice Admiral Jerome M. Adams, M.D., MPH, Surgeon General of the United States are scheduled to testify. On September 23, the HELP Committee will hold a hearing on the federal response to COVID-19. Director of NIH’s National Institute of Allergy and Infectious Diseases Anthony Fauci, M.D., Director of the Centers for Disease Control and Prevention (CDC) Robert Redfield, M.D., HHS Assistant Secretary for Health Adm. Brett Giroir, M.D. and FDA Commissioner Stephen Hahn, M.D. are scheduled to testify.
• NIH announced $129.3 million in scale up and manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative. NIH is awarding contracts to nine companies for technologies that include portable point-of-care tests for immediate results and high-throughput laboratories.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

August 27, 2020

• FDA warned consumers about alcohol-based hand sanitizer products that are packaged in containers that may appear as food and drinks.
• FDA authorized the emergency use of the BinaxNOW COVID-19 Ag Card antigen test. FDA press release here.
• FDA announced that it would convene its Advisory Committee for Vaccines and Related Biological Products on October 22, 2020. The Federal Register Notice announcing the meeting stated that no specific application will be discussed but that the committee will discuss, in general, the development, authorization and/or licensure of vaccines to prevent COVID-19.

August 26, 2020

• FDA published a laboratory analytical procedure to assess the quality of finished hand sanitizer products.
• Valerie Jensen, Associate Director of the Drug Shortages Staff in FDA’s Center for Drug Evaluation and Research and Dr. Anand Shah, FDA Deputy Commissioner for Medical and Scientific Affairs, addressed drug shortages and COVID-19.
• The Centers for Disease Control and Prevention (CDC) revised its Overview of Testing for COVID-19.

August 25, 2020

• FDA established a webpage on pooled testing and screening testing for COVID-19.

August 24, 2020

• FDA authorized the use of convalescent plasma for the treatment of hospitalized patients with COVID-19. FDA’s Clinical Memorandum assessing the Emergency Use Authorization request here and FDA press release here.

August 21, 2020

• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA and the Occupational Safety and Health Administration (OSHA) published an Employee Health and Food Safety Checklist for human and animal food operations use during the COVID-19 pandemic.

August 20, 2020

• FDA published guidance on manufacturing, supply chain, and drug and biological product inspections during the COVID-19 pandemic.
• HHS rescinded guidances and other informal issuances concerning premarket review of laboratory developed tests (LDTs).
• FDA issued an EUA for a COVID-19 antigen test that detects antigens to SARSCoV-2 directly from nasal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first twelve days of the onset of symptoms.
• FDA posted an FAQ for consumers about UV lights and lamps that may be used to disinfect surfaces in the home or similar spaces during the COVID-19 pandemic.
• FDA and FTC continue to issue Warning Letters (here and here) with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

August 19, 2020

• Dr. Judy McMeekin, Associate Commissioner for Regulatory Affairs, joined Dr. Anand Shah, Deputy Commissioner for Medical and Scientific Affairs, on the FDA Insight Podcast to discuss health fraud and COVID-19.

August 18, 2020

• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

August 17, 2020

• FDA authorized the emergency use of the Yale School of Public Health’s SalivaDirect COVID-19 test. The test does not require swabs or a collection device as saliva may be collected in any sterile container. FDA press release here.

August 13, 2020

• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA warned four companies (see Fair Price Labs, Inc., CoreMedica Laboratories, Inc, Holistic Health International, LLC, AkivaMed Inc.) for allegedly selling unapproved and unauthorized COVID-19 tests for at-home use and/or sample collection. 

August 12, 2020

• FDA posted two webpages regarding regulatory requirements for medical devices during the COVID-19 pandemic: FAQs on Importing Medical Devices During the COVID-19 Pandemic and FAQs on Registration and Listing of Medical Devices During the COVID-19 Pandemic.

August 11, 2020

• FDA updated its three guidance documents regarding hand sanitizer products produced during the COVID-19 pandemic: 1) temporary policy for the manufacture of alcohol for incorporation into alcohol-based hand sanitizer products; 2) temporary policy for the preparation of certain alcohol-based hand sanitizer products; and 3) policy for the temporary compounding of certain alcohol-based hand sanitizer products
• FDA continues to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA authorized the emergency use of the George Washington University Public Health Laboratory COVID-19 molecular test. 

August 10, 2020

• FDA updated its Coronavirus Treatment Acceleration Program (CTAP) webpage with new information regarding the status of COVID-19 therapeutic treatments.
• FDA revoked the Emergency Use Authorization for an Anti-SARS-CoV-2 Rapid Test which tests coronavirus antibodies.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA announced that it would convene a meeting of the Vaccines and Related Biological Products Advisory Committee on October 2, 2020. In a recent article in the Journal of the American Medical Association (JAMA), FDA leadership confirmed that Advisory Committee review will be needed prior to authorization or licensure of a COVID-19 vaccine.

August 7, 2020

• FDA issued an umbrella Emergency Use Authorization (EUA) for disposable, single-use surgical masks for use in healthcare settings.
• President Trump signed an Executive Order entitled “Ensuring Essential Medicines, Medical Countermeasures, and Critical Inputs are Made in the United States.

August 6, 2020

• The National Institutes of Health launched the Medical Imaging and Data Resource Center (MIDRC) to utilize artificial intelligence and medical imaging for COVID-19 diagnosis, treatment, and monitoring. 

August 5, 2020

• On August 5th from 12:15 to 1:15 PM (EST), FDA convened its weekly Virtual Town Hall  for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

August 4, 2020

• FDA Commissioner, Stephen M. Hahn M.D., and Deputy Commissioner for Medical and Scientific Affairs, Anand Shah M.D., authored an article in FDA Voices regarding investing in advanced manufacturing to support public health preparedness. 
• On August 4th, 12:00 – 1:00 pm (EST), FDA hosted a webinar on the regulation of face masks and surgical masks during the COVID-19 pandemic. 

August 3, 2020

• FDA authorized the emergency use of the Attelica IM and the ADVIA Centaur, the first two COVID-19 serology tests that display an estimated quantity of antibodies present in an individual’s blood. FDA press release here.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• The Occupational Safety and Health Administration published new FAQs relating to COVID-19 masks. 

July 31, 2020

• FDA established a Q&A webpage  for consumers and patients addressing COVID-19 antibody testing. 
• FDA updated its Q&A webpage regarding Food Safety and the Coronavirus. 

July 30, 2020

• FDA published a new template to facilitate the preparation and submission of Emergency Use Authorizations for manufacturers of molecular and antigen diagnostic COVID-19 tests for non-laboratory use.
• FDA updated the templates for molecular COVID-19 diagnostic tests developed by commercial manufacturers and laboratories.

July 29, 2020

• Dr. Peter Marks, the Director of FDA’s Center for Biologics Evaluation and Research, spoke on FDA’s podcast series about the development of COVID-19 vaccines. 
• On July 29th from at 12:15-1:15pm (EST) FDA convened its weekly Virtual Town Hall on COVID-19 Diagnostic Tests. 
• FDA issued an Emergency Use Authorization to Eli Lilly and Company for a SARS-CoV-2 Assay.  

July 27, 2020

• FDA reissued LabCorp’s Emergency Use Authorization (EUA) for COVID-19 RT-PCR Test with two new indications: the testing of asymptomatic individuals and pooled sample testing. This is the first diagnostic test for the screening of individuals without known or suspected COVID-19 Infection. FDA press release here.
• The Department of Health and Human Services issued a request for information (RFI), seeking information from the diagnostic community on their ability to rapidly produce American-made point of care antibody tests for COVID-19.

July 24, 2020

• FDA updated a resource on COVID-19 testing supply substitution strategies for labs performing authorized COVID-19 tests. 
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• The Department of Justice (DOJ) issued a business review letter to monoclonal antibody manufacturers to expedite and increase the production of such COVID-19 treatments. 
• The Centers for Disease Control (CDC) published information regarding the reopening of America’s schools. The CDC also updated its guidance for screening K-12 school students for symptoms of COVID-19. 

July 23, 2020

• FDA established a new webpage on Cancer and COVID-19. 

July 22, 2020

• Director of FDA’s Center for Devices and Radiological Health Jeffrey E. Shuren, M.D., J.D. published a statement regarding the Agency’s on-going work to support and advance COVID-19 diagnostic test accuracy and availability. 
• On July 22nd from 12:15 to 1:15 (ET), FDA held its weekly Virtual Town Hall on diagnostic testing for COVID-19 testing.  
• FDA provided written testimony to the Senate Subcommittee on Manufacturing, Trade, and Consumer Protection on protecting Americans from COVID-19 scams. 
• The Department of Health and Human Services launched the National Testing Implementation Forum to enhance collaboration between the federal and private sectors with respect to COVID-19 testing.

July 20, 2020

• FDA reissued an Emergency Use Authorization for Quest Diagnostics to authorize its molecular diagnostic test for use with certain pooled samples. FDA press release here.

July 17, 2020

• On July 17th, FDA will close its COVID-19 Industry Hotline. The agency will continue to provide support for industry and laboratory questions about COVID-19 and medical devices through a directory of Contacts for Medical Devices during the COVID-19 Pandemic.

July 16, 2020

• FDA updated its FAQ on COVID-19 testing to include a list of laboratories and commercial manufacturers whose tests are no longer authorized under the Policy for COVID-19 Tests During the Public Health Emergency.  

July 15, 2020

• FDA updated information on its Coronavirus Treatment Acceleration Program (CTAP) webpage. See FDA statement here.
• FDA added dexamethasone sodium phosphate to lists for temporary compounding by outsourcing facilities and pharmacy compounders during the COVID-19 pandemic.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA authorized the emergency use of Compass Laboratory Services SARS-CoV-2 Assay, a molecular diagnostic test. 

July 14, 2020

• FDA announced its New Era of Smarter Food Safety Blueprint. The Blueprint consists of four core elements: tech-enabled traceability, smarter tools and approaches for prevention and outbreak response, new business models and retail modernization, and food safety culture.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

July 13, 2020

• On July 10th, FDA announced that it would prepare to resume domestic inspections, utilizing a specified risk assessment system. 
• FDA authorized the emergency use of gammaCore Sapphire CV, a non-invasive Vagus nerve stimulator. 
• HHS released State Testing Plans for May and June.

July 10, 2020

• FDA announced that a U.S. District Court in Florida issued a permanent injunction and default judgment against Genesis II Church and two other defendants for violating federal law in connection with the sale of a fraudulent COVID-19 treatment. The order permanently prohibits the defendants from selling or distributing unapproved or misbranded products.
• The World Health Organization announced that it will initiate an Independent Panel for Pandemic Preparedness and Response (IPPR) to evaluate the global response to COVID-19. 

July 9, 2020

• Federal prosecutors in the Southern District of Florida charged four Florida residents, who allegedly marketed a “miracle” bleach solution to treat COVID-19, with conspiracy to defraud the United States, conspiracy to violate the Federal Food, Drug, and Cosmetic Act (FDCA), and criminal contempt. The move came after an FDA Warning Letter and civil order allegedly failed to achieve compliance.
• FDA continues to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• The Government Accountability Office (GAO) released a report on herd immunity for COVID-19.

July 7, 2020

• FDA continues to warn consumers and healthcare providers about the dangers associated with hand sanitizers containing methanol (wood alcohol). FDA updated the list of hand sanitizer products that have tested positive for methanol contamination.
• FDA will host a Virtual Town Hall on July 8th from 12:15-1:15 pm (EST) for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19.
• FDA updated its guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic.

July 6, 2020

• FDA updated its warning to consumers and healthcare professionals about certain hand sanitizer products that contain methanol (wood alcohol).
• FDA issued a warning Letter with respect to an at-home blood sample collection kit for COVID-19 serology testing, alleging that the product was adulterated and misbranded under the Food, Drug and Cosmetic Act.

July 2, 2020

• FDA distributed the first round of coronavirus reference panel materials which are to be used to support the development of COVID-19 diagnostic tests. 
• FDA authorized the emergency use of the Kroger Health COVID-19 Test Home Collection Kit.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

July 1, 2020

• FDA published guidance on the development and licensure of vaccines to prevent COVID-19. See FDA press release here.
• The Department of Health and Human Services (HHS) announced that it would extend its partnership with certain national pharmacy and grocery retail chains to continue community-based COVID-19 testing.
• The testimony of FDA Commissioner, Stephen M. Hahn, M.D., CDC Director, Robert Redfield, M.D., Director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, M.D., and HHS Assistant Secretary for Health, Adm. Brett Giroir, M.D. before the June 30th Senate Health, Education, Labor & Pensions Committee meeting can be found here.

June 30, 2020

• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• HHS spokesperson Michael Caputo tweeted that HHS intends to extend the COVID-19 public health emergency declaration that is set to expire on July 25th. The extension would prolong the public health emergency for another 90 days. Modern Healthcare Article here.

June 29, 2020

• FDA updated the templates to be used by laboratories and commercial manufacturers of serology and antibody tests in preparing Emergency Use Authorization (EUA) requests. 
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA published an update to its guidance on the review and update of device establishment inspection processes and standards. 
• The Government Accountability Office (GAO) published a report on key considerations for agencies returning employees to workplaces during pandemics. 
• FDA Commissioner, Stephen M. Hahn, M.D., CDC Director, Robert Redfield, M.D., Director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, M.D., and HHS Assistant Secretary for Health, Adm. Brett Giroir, M.D. will testify before the Senate Committee on Health, Education, Labor & Pensions on June 30th at 10 am (ET).  The Hearing is entitled “ Update on Progress Toward Safely Getting Back to Work and Back to School.”

June 26, 2020

• FDA published a statement on partnering with the European Union and global regulators on COVID-19. In connection with that partnership, FDA held a bilateral meeting with EMA and the European Commission (EC) to discuss regulatory cooperation in medical product areas, including issues related to COVID-19.
• The Government Accountability Office (GAO) published a report on the opportunities to improve federal response and recovery efforts relating to the COVID-19 public health emergency. 

June 25, 2020

• USDA and FDA issued a joint statement on food export restrictions pertaining to COVID-19.

June 24, 2020

• FDA Commissioner Stephen M. Hahn, M.D. issued a statement that FDA has maintained the pace of meeting its goals on review applications for medical products during the pandemic.
• FDA is partnering with the Critical Path Institute and the National Center for Advancing Translational Sciences (part of the National Institutes of Health) on the CURE Drug Repurposing Collaboratory (CDRC). The partnership will allow the exchange of clinical practice data to inform potential new uses of existing drugs for areas of high unmet medical need. A pilot program will collect data from FDA’s CURE ID platform for potential drug repurposing for COVID-19 treatments.
• FDA hosted its weekly Virtual Town Hall on Diagnostic Testing on June 24th from 12:15 - 1:15 pm (ET).
• FDA published a Consumer Update on food safety during the pandemic.
• FDA Commissioner, Stephen M. Hahn, M.D., CDC Director, Robert Redfield, M.D., Director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, M.D., and HHS Assistant Secretary for Health, Adm. Brett Giroir, M.D. testified before the House Committee on Energy and Commerce on June 23rd. Their written testimony can be found here.

June 23, 2020

• FDA published guidance on the effects of the COVID-19 public health emergency on formal meetings and user fee applications for medical devices.
• FDA hosted a Webinar on June 23rd from 12:00 pm – 1:00 pm (ET) regarding respirators for healthcare personnel use during the COVID-19 pandemic.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

June 22, 2020

• FDA published guidance on good manufacturing practice (GMP) considerations for responding to COVID-19 infection in employees in drug and biological manufacturing.
• FDA updated its guidance on notifying CDRH of a permanent discontinuance or interruption in the manufacturing of a device under section 506j of the Food, Drug and Cosmetic Act during the COVID-19 pandemic.
• FDA published an update on the use of 3D printing in FDA’s response to COVID-19.
• The FDA and the FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.
• FDA advised consumers not to use hand sanitizers manufactured by Eskbiochem SA de CV in Mexico due to the potential presence of methanol (wood alcohol) that can be toxic when absorbed through the skin or ingested.

June 19, 2020

• FDA published FAQs related to its policy regarding certain food labeling requirements during the COVID-19 pandemic for minor formulation changes and vending machines.
• FDA continues to take action regarding real-world data to inform its COVID-19 response efforts. The agency will participate in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. FDA press release here.
• FDA Commissioner, Stephen Hahn, MD, CDC Director, Robert Redfield, MD, Director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, MD, and HHS Assistant Secretary for Health, Adm. Brett Giroir, MD will testify before the Senate Health, Education, Labor & Pensions (HELP) Committee on June 30th. The hearing is entitled “COVID-19: Update on Progress Toward Safely Getting Back to Work and Back to School.”

June 18, 2020

• FDA issued Warning Letters (see Medakit, Ltd., Antibodiescheck.com and Sonrisa Family Dental dba mycovidtest19.com) with respect to alleged adulterated and misbranded COVID-19 antibody tests. FDA press release here.

June 17, 2020

• FDA issued guidance on statistical considerations for clinical trials during the COVID-19 public health emergency. 
• FDA revoked an Emergency Use Authorization (EUA) for a COVID-19 antibody test due to concerns about test accuracy. FDA press release here.
• FDA updated its EUA templates for the validation of molecular diagnostic tests by manufacturers and laboratories. FDA press release here.
• FDA posted a Question and Answer on its website regarding adverse event reporting for medical devices under Emergency Use Authorizations or discussed in COVID-19 related guidance documents. 
• FDA issued two new EUAs (see Negative-pressure Respirator System with Advanced Ventilation Return (NRSAVR-100) and Technical Safety Services VHP Decontamination System) for personal protective equipment (PPE). 
• FDA hosted its weekly Virtual Town Hall on Diagnostic Testing for COVID-19 on June 17th from 12:15pm - 1:15pm (ET).

June 15, 2020

• FDA issued a Warning Letter with respect to alleged false and misleading claims that an exosome product is safe and/or effective for the treatment or prevention of COVID-19.

June 12, 2020

• FDA issued an FAQ to address questions regarding the design, evaluation, labeling, and marketing of hospital beds, stretchers, and mattresses during the COVID-19 pandemic.
• FDA authorized the emergency use (see InBios Int’l SCoV-2 Detect IgG ELISA and Cue Health Inc. COVID-19 Test) of a COVID-19 antibody test and a COVID-19 point of care diagnostic test kit.
• FDA issued a statement regarding its prioritization of rare disease therapy development and access during the COVID-19 public health emergency.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.

June 10, 2020

• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.
• FDA authorized the emergency use (see Dimension Vista SARS-CoV-2 Total Antibody Assay and Dimension EXL SARS-CoV-2 Total Antibody Assay) of two additional COVID-19 antibody tests.

June 9, 2020

• FDA issued a temporary policy on the Prescription Drug Marketing Act requirements for the distribution of drug samples during the COVID-19 public health emergency.
• FDA established two new web pages addressing the COVID-19 pandemic: Innovation to Respond to COVID-19 and COVID-19 Educational Resources.
• FDA hosted a Webinar on June 9th from 12:00 - 1:00 pm (ET) addressing respirators for healthcare personnel use during the COVID-19 pandemic. This webinar will be part of a series and will include speakers from FDA, CDC, NIOSH and OSHA.
• FDA hosted a Drug Topics Webinar on June 9th at 1:00 pm (ET) entitled “CURE ID: Capturing Clinician’s Experiences Repurposing Drugs to Inform Future Studies in the Era of COVID-19.” Registration is required.
• FDA authorized the emergency use of a ventilator for adult patients requiring mechanical ventilation under the umbrella ventilator Emergency Use Authorization (EUA).

June 8, 2020

• FDA reissued certain Emergency Use Authorizations (EUAs), revising which types of respirators can be decontaminated for reuse. FDA press release here.
• FDA revised its enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the COVID-19 pandemic.
• FDA authorized the emergency use (see Vibrant America Clinical Labs and Hangzhou Biotest Biotech Co., Ltd.) of two new serology tests.
• FDA has changed the hours for its COVID-19 Industry Hotline. The Hotline (1-888-INFO-FDA, press *) will operate from 8 am to 8 pm (ET), Monday through Friday. FDA will maintain an Emergency Line (1-866-300-4374) after hours for urgent inquiries. See here.
• FDA published independent evaluations of four COVID-19 serological tests kits. FDA press release here.

June 5, 2020

• FDA is launching a webinar series on respirators for healthcare personnel use during the COVID-19 pandemic. Speakers will include FDA Commissioner Stephen M. Hahn, M.D. and Director of the Center for Devices and Radiological Health Jeffrey E. Shuren, M.D., J.D.
• FDA published a letter to clinical laboratory staff and healthcare providers reminding them to use transport media that are compatible with the COVID-19 testing platforms and processes used in their laboratories to process samples collected from individuals who are being tested for COVID-19.
• FDA updated its temporary policy regarding preventative controls and FSVP food supplier verification onsite audit requirements during the COVID-19 pandemic.
• FDA continues to issue Warning Letters (see Roidsmall.net, Emedkit.com, 4nrx.md, Chloroquineonline.com) with respect to alleged false and misleading claims that certain products are safe and/or effective for the treatment of COVID-19.

June 4, 2020

• FDA published a resource for laboratories performing authorized COVID-19 tests, addressing testing supply substitution strategies.
• FDA updated its guidance on the conduct of clinical trials of medical products during the COVID-19 public health emergency.
• FDA authorized the emergency use of an immunoassay used to assist in the identification of severe inflammatory response in the plasma of patients with confirmed COVID-19 to aid in determining the risk of intubation with mechanical ventilation.

June 3, 2020

• FDA published guidance on Institutional Review Board (IRB) review of individual patient expanded access requests for investigational drugs and biological products during the COVID-19 public health emergency.
• FDA and the European Medicines Agency (EMA) issued Common Commentary on submitting an initial pediatric study plan (iPSP) and pediatric investigation plan (PIP) for new drugs and biological products for the prevention and treatment of COVID-19.
• FDA Commissioner Stephen M. Hahn, M.D. and Deputy Commissioner for Food Policy and Response, Frank Yiannas, discussed how challenges encountered during the pandemic highlight the importance of ushering in a new era of smarter food safety.
• FDA leaders testified before the U.S. Senate Committee on Finance regarding oversight of the FDA’s foreign drug manufacturing inspection process during COVID-19 and beyond. Testimony here.
• FDA authorized the emergency use (see ventilator Emergency Use Authorization, and Appendix B) of two new ventilators, including a ventilator from NASA.
• FDA hosted its weekly Virtual Town Hall on the agency’s Guidance on COVID-19 Diagnostic Tests on June 3rd from 12:15 pm - 1:15 pm (EST).

June 2, 2020

• FDA updated three temporary policies relating to the manufacture and compounding of alcohol-based hand sanitizers during the COVID-19 pandemic (manufacture of alcohol for incorporation into alcohol- based hand sanitizers, preparation of certain alcohol-based hand sanitizers, and compounding of certain alcohol-based hand sanitizers). FDA press release here.
• FDA Commissioner Stephen Hahn, M.D. made a speech about the COVID-19 pandemic.

June 1, 2020

• FDA released a template for Emergency Use Authorizations for at-home sample collection kits. The template provides FDA’s current recommendations on the data and information developers should submit to the agency to facilitate the authorization process. FDA press release here.
• FDA Commissioner Dr. Stephen Hahn published an update on FDA’s response to the COVID-19 public health emergency.
• FDA published a Consumer Update to help consumers understand the regulatory terminology surrounding the potential preventions and treatments for COVID-19.
• FDA authorized three additional serology/antibody tests (see Atellica, ADVIA, Healgen).
• FDA continues to issue Warning Letters (see Quadrant Sales & Marketing, Inc. and StayWell Copper Products) with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.

May 29, 2020

• FDA authorized the emergency use of a N95 Respirator Decontamination System (RDS).

May 28, 2020

• FDA issued guidance on the effect of the COVID-19 public health emergency on formal meetings with CDER and CBER and user fee applications.
• FDA announced that it is providing a new tool, a SARS-CoV-2 reference panel, to commercial and laboratory developers who are interacting with the FDA through the pre-emergency use authorization (EUA) process, to aid in the development and evaluation of diagnostic tests that detect the coronavirus.
• FDA published guidance on reporting a temporary closure or significantly reduced production by a human food establishment and requesting FDA assistance during the COVID-19 pandemic.
• FDA revised its enforcement policy for face masks and respirators during the COVID-19 public health emergency.
• FDA published recommendations for sponsors requesting Emergency Use Authorizations (EUAs) for decontamination and bioburden reduction systems for face masks and respirators during the COVID-19 pandemic. The agency also published a letter to healthcare providers about the correct use of certain authorized sterilization systems to decontaminate respirators.
• FDA authorized the emergency use of a predictive screening device to be used by healthcare providers with adult patients in the intensive care unit for the computation of patient status indices as adjunct patient monitoring during the COVID-19 pandemic.
• FDA and FTC continue to issue Warning Letters (see CBD Gaze, Alternavita, Musthavemom.com, and Careful Cents LLC) with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.
• GAO published a Science and Tech Spotlight on COVID-19 vaccine development.

May 27, 2020

• FDA held a Virtual Town Hall on May 27, 2020, from 12:15 pm - 1:15 pm (ET) for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19.

May 26, 2020

• FDA and the U.S. Department of Agriculture (USDA) published considerations for those in the food and agriculture sectors experiencing shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies during the COVID-19 pandemic. Constituent update here.
• FDA issued a temporary policy regarding labeling for minor food formulation changes and certain vending machine food labeling requirements related to calorie declarations during the COVID-19 public health emergency. Constituent update here.
• FDA published a temporary policy regarding the qualified exemption from the standards of growing, harvesting, packing, and holding produce for human consumption (21 C.F.R. Part 112) for the duration of the COVID-19 pandemic.
• FDA authorized the emergency use of certain gowns and other apparel for use by healthcare personnel as personal protection equipment (PPE) in healthcare settings in accordance with CDC recommendations to protect both healthcare personnel and patients from the transfer of SARS-CoV-2 in low or minimal risk level situations to prevent the spread of COVID-19.
• FDA updated its FAQ on Testing to include a list of tests that should no longer be distributed for COVID-19. This update follows the posting of a list of commercial serology tests removed from the “notification list,” which had allowed the tests to be distributed under FDA’s testing policy. The FAQ was also updated to include a question on at-home sample collection for certain authorized tests. This follows the authorization of saliva and nasal swab at-home collection to test for Coronavirus.
• FDA and FTC continue to issue Warning Letters (see Apollo Holding LLC and North Coast Biologics) with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.

May 22, 2020

• FDA posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for COVID-19 Tests. The list can be found in the Diagnostic Testing FAQ. FDA press release here.
• FDA issued a guidance on supplements for approved premarket approval (PMA) or humanitarian device exemption (HDE) submissions during the COVID-19 public health emergency.
• FDA updated two temporary policies on the compounding of drugs by certain pharmacy compounders and outsourcing facilities during the COVID-19 pandemic.
• FDA authorized the emergency use of a product for decontaminating compatible N95 respirators for single-user reuse by healthcare personnel where there are insufficient supplies of face-filtering respirators due to the COVID-19 pandemic.
• FDA issued an Emergency Use Authorization for a device intended to provide continuous renal replacement therapy (CRRT) to treat patients in an acute care environment who have acute renal failure, fluid overload, or both during the COVID-19 pandemic.
• As result of an order issued by the U.S. District Court for the Eastern District of Texas (See R.J. Reynolds Tobacco Co. et al. v. FDA et al., No. 6:20-cv-00176 (E.D. Tex. Apr. 3, 2020)), the effective date of the FDA final rule on “Required Warnings for Cigarettes Packages and Advertisements” was postponed by 120 days. The new effective date of the final rule is October 16, 2021. FDA announced that it intends to update its relevant guidances related to the rule’s effective date and the timing for submission of cigarette plans. FDA announcement here.

May 21, 2020

• FDA issued an Emergency Use Authorization (EUA) to Walter Reed National Military Medical Center for the COVID-19 Airway Management Isolation Chamber (CAMIC). The barrier device, which helps prevent exposure to the coronavirus, is to be used by healthcare providers within the U.S. Army and Military Health System.
• FDA and FTC continue to issue Warning Letters (see Life Unlearned LLC and SpiceTac) with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.

May 20, 2020

• FDA announced a collaboration with Aetion to use advanced analytical techniques, including real world data, to answer urgent COVID-19 research questions.
• FDA and the United States Department of Agriculture (USDA) entered into a Memorandum of Understanding regarding the potential use of the Defense Production Act to help prevent interruptions at FDA-regulated food facilities during the COVID-19 public health emergency. Press release here.
• FDA issued revised guidance on the implementation of acceptable full-length and abbreviated donor history questionnaires and accompanying materials for use in screening donors of source plasma.

May 19, 2020

• FDA published a supply chain update regarding the importation of vital food and medical products during the COVID-19 public health emergency.
• FDA and FTC continue to issue Warning Letters (see Neotic Nutraceuticals and The Golden Road Kratom) with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.
• FDA will hold its weekly Virtual Town Hall on Diagnostic Testing on May 20th from 12:15 pm - 1:15 pm (EST).

May 18, 2020

• FDA authorized the emergency use of the first stand-alone, at-home sample collection kit to be used with certain authorized COVID-19 tests. FDA Press Release here.
• FDA issued a publication for consumers entitled “Coronavirus Testing Basics.” The publication describes the different types of tests authorized by FDA - molecular tests, serology tests, and antigen tests.
• FDA issued an Emergency Use Authorization (EUA) for a patch intended to be used by healthcare professionals in the hospital setting for remote monitoring of the QT interval of an electrocardiogram (ECG) in adult COVID-19 patients undergoing treatment with drugs that may cause life-threatening cardiovascular complications.
• FDA and FTC continue to issue Warning Letters (see dietary supplements and herbal products) with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.
• The White House released its plans for “Operation Warp Speed,” a national program aimed at accelerating the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics. FDA Center Directors Dr. Peter Marks (CBER) and Dr. Janet Woodcock (CDER) will serve on the operation’s leadership team. See President Trump’s remarks on the Operation here and Department of Health and Human Services press release here.
• FDA published Contacts for Medical Devices During the COVID-19 Pandemic. This list contains FDA email addresses that can be used to ask questions, e.g., policies with respect to specific devices, EUAs, and device shortages.

May 15, 2020

• FDA authorized the emergency use of infusion pumps and infusion pump accessories for use by healthcare providers to treat conditions caused by COVID-19.
• FDA published a temporary policy regarding non-standard personal protective equipment (PPE) practices for sterile compounding by pharmacy compounders not registered as outsourcing facilities during the COVID-19 pandemic.
• A federal judge entered a temporary restraining order to prevent the distribution of certain colloidal silver products claiming to treat coronavirus and other diseases. FDA and FTC had previously issued a Warning Letter to the defendants regarding their colloidal silver products. FDA press release here.

May 14, 2020

• FDA held a Virtual Town Hall on 3D Printed Swabs on Friday, May 15th from 1pm to 2pm (EST). The Virtual Town Hall is a collaboration between FDA, the Department of Veterans Affairs’ Innovation Ecosystem, and the National Institutes of Health’s 3D Print Exchange.
• FDA established a webpage on the use of thermal imaging systems (infrared thermographic systems/thermal imaging cameras) during the COVID-19 public health emergency.

May 13, 2020

• FDA updated its snapshot of the Coronavirus Treatment Acceleration Program (CTAP). As of May 13th, there are 144 active trials of therapeutic agents to treat COVID-19 and there are another 457 development programs for therapeutic agents in the planning stages.
• FDA established a webpage on drug development inquiries for drugs to address the COVID-19 pandemic.
• FDA authorized the emergency use of a remote communication and monitoring device for use by healthcare providers and patients in certain healthcare environments.
• FDA updated its guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic.
• FDA issued an Emergency Use Authorization (EUA) for an electrocardiogram (ECG) low ejection fraction tool (ELEFT) to be used by healthcare professionals with certain adult patients having or suspected of having COVID-19.
• FDA updated information for blood establishments regarding the COVID-19 outbreak.
• FDA published guidance on returning refrigerated transport vehicles and refrigerated storage units to food uses after using them to preserve human remains during the COVID-19 pandemic.
• FDA continues to issue Warning Letters with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.

May 12, 2020

• FDA issued guidance regarding general considerations for pre-IND (investigational new drug) meeting requests for COVID-19 related drugs and biological products.
• FDA issued guidance for developing drugs and biological products for the treatment or prevention of COVID-19. The guidance does not apply to preventative vaccines or convalescent plasma. FDA press release here.
• FDA issued guidance on postmarketing adverse event reporting for medical products and dietary supplements during the COVID-19 pandemic.
• FDA issued a policy to help accelerate the availability of novel COVID-19 tests developed by laboratories and commercial manufacturers for the duration of the public health emergency.
• FDA is collaborating with the Center for Disease Control (CDC) to develop a process that would govern how and where to return to on-site facility surveillance inspections in accordance with the White House’s guidelines for opening up America again. FDA press release here.
• FDA updated a list of respirator models no longer authorized for emergency use during the COVID-19 pandemic. All respirators are manufactured in China.
• FDA and FTC continue to issue Warning Letters (see Seanjari Preeti Womb Healing LLC and Plum Dragon Herbs, Inc.) with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.

May 11, 2020

• FDA authorized the emergency use of a COVID-19 diagnostic test that allows for saliva sample collection at-home or in a healthcare setting. This is the first FDA-authorized diagnostic test that allows for home-collected saliva samples. FDA Press Release here.
• FDA authorized the first emergency use of a COVID-19 antigen test for the rapid detection of Coronavirus. FDA press release here.
• FDA and FTC continue to issue Warning Letters (see Sanit Technologies, AgroTerra, Ltd., WashingtonLastFrontier.com and Chronic Lyme Treatments) with respect to alleged false and misleading claims that certain consumer products are safe and/or effective for the treatment of COVID-19.
• FDA issued an Emergency Use Authorization for a Patient Isolation Transport Unit (PITU) device intended to be used by healthcare providers for temporary isolation and transport of patients with suspected or confirmed COVID-19.

May 8, 2020

• FDA reissued the Emergency Use Authorization (EUA) for non-NIOSH-approved respirators manufactured in China. Changes to the EUA resulted from FDA findings that certain respirators did not meet expected performance standards. FDA posted a letter to healthcare providers regarding the status of these respirators.
• FDA authorized the emergency use of a diagnostic test using CRISPR technology.
• FDA issued an update on its efforts to combat allegedly fraudulent products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. To date, FDA has issued 42 warning letters to companies selling such products. 
• FDA’s Center for Veterinary Medicine (CVM) issued guidance on reporting and mitigating animal drug shortages during the COVID-19 pandemic. FDA press release here.
• FDA issued a letter to healthcare providers about the risk of misinterpreting hydrogen peroxide indicator colors for vapor sterilization.  
• FDA issued best practices for the re-opening of retail food establishments closed or partially closed due to the COVID-19 pandemic. FDA included a retailer checklist and infographic.

May 7, 2020

• FDA issued guidance on notifying FDA’s Center for Devices and Radiological Health (CDRH) of a permanent discontinuance or interruption in the manufacturing of a device under Section 506J of the Food, Drug, and Cosmetic Act during the COVID-19 pandemic. FDA will be hosting a webinar on the guidance on May 11th at 2pm (EST).
• FDA created a dedicated webpage addressing EUA authorized serology test performance.
• FDA Commissioner Dr. Stephen Hahn and other government health officials will testify before the Senate Committee on Health, Education, Labor and Pensions on “Safely Getting Back to Work and Back to School.” The hearing is scheduled for May 12th at 10am (EST). Other scheduled speakers include Anthony Fauci, MD, Director, National Institute of Allergy and Infectious Diseases, National Institutes of Health; Robert Redfield, MD, Director, United States Centers for Disease Control and Prevention; and Admiral Brett Giroir, MD, Assistant Secretary For Health, United States Department of Health and Human Services.

May 6, 2020

• FDA authorized the emergency use of an ECG-QT Analysis System for use by healthcare professionals in the healthcare setting to treat certain COVID-19 patients. The device is used to remotely monitor and detect changes in a patient’s QT interval as measured by an electrocardiogram (ECG).
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain silver-containing products and homeopathic products are safe and/or effective for the treatment of COVID-19.
• FDA approved two generic drugs, succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL, indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. FDA announcement here.
• On May 6th, FDA hosted a Virtual Town Hall on diagnostic testing.

May 5, 2020

• FDA revised its policy on COVID-19 diagnostic testing. See FDA’s discussion of its revised policy here and updated FAQs on diagnostic testing here.
• FDA authorized the emergency use of the first serology test under its new umbrella authorization pathway.
• FDA continues to issue Warning Letters with respect to alleged false and misleading claims that products (see: Antroids.com and Foxroids.com) are safe and/or effective for the treatment of COVID-19.

May 4, 2020

• FDA authorized the emergency use of remdesivir to treat certain patients hospitalized with COVID-19. FDA press release here.
• FDA updated its guidance on Investigational COVID -19 Convalescent Plasma. FDA Investigational COVID-19 Convalescent Plasma webpage here.
• FDA issued an Emergency Use Authorization (EUA) to Manufacturers of Protective Barrier Enclosures; Health Care Providers; Hospital Purchasing Departments and Distributors; and Any Other Stakeholders for protective barrier enclosures, a transparent device designed to cover a patient’s head and upper body that incorporates one or more ports through which a healthcare provider’s hands are passed to perform a medical procedure.
• FDA authorized the emergency use of a respiratory muscle simulator and a continuous renal replacement therapy (CRRT) device.

May 1, 2020

• FDA issued guidance on exemptions and exclusions from certain requirements of the Drug Supply Chain Security Act (DSCSA) during the COVID-19 pandemic.
• FDA authorized the emergency use of a ventilator developed by the National Aeronautic and Space Administration (NASA) under FDA’s existing Ventilator Emergency Use Authorization for certain ventilators, ventilator tubing connectors, and ventilator accessories. See FDA news release here.
• FDA announced that it has authorized the emergency use of 53 diagnostic tests, including 9 serology tests.
• FDA published Questions and Answers about COVID-19 and pets. 

April 30, 2020

• FDA issued an Emergency Use Authorization (EUA) for SARS-CoV-2 Antibody Tests that have been evaluated in an independent validation study performed at the National Institutes of Health’s National Cancer Institute or performed by another government agency designated by FDA, and are confirmed by FDA to meet criteria set forth in the EUA. The devices must be used in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform moderate or high complexity tests.
• FDA continues to update various FAQs regarding critical medical devices needed during the COVID-19 public health emergency. For example, the agency’s website includes an FAQ on Ventilators and an FAQ on Medical Devices approved during the pandemic.
• The Department of Justice announced that a federal court in Utah entered a temporary injunction halting the sale of certain silver products for the diagnosis, cure, mitigation, treatment, or prevention of any disease, including COVID-19. A hearing on the government’s request for a preliminary injunction is set for May 12, 2020. FDA also issued a press release regarding the order.
• FDA hosted a webinar on conducting clinical trials of medical products during the COVID-19 public health emergency.

April 29, 2020

• FDA posted a video describing Emergency Use Authorizations (EUAs).
• FDA posted information regarding bioequivalence studies for submission in Abbreviated New Drug Applications (ANDAs) during the COVID-19 pandemic.
• FDA and FTC issued Warning Letters with respect to alleged false and misleading claims that certain consumer products (see Hopewell Essential Oils and Santiste Labs LLC) are safe and/or effective for the treatment of COVID-19.
• FDA hosted a Virtual Town Hall on April 29th for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19.

April 28, 2020

• The Trump Administration announced a Testing Blueprint for testing plans and rapid response programs that “describes a partnership between Federal, State, local, and tribal governments, along with the private sector and professional associations” to meet the country’s testing needs.
• FDA reissued an Emergency Use Authorization (EUA) for face masks to “Manufacturers of Face Masks; Health Care Personnel; Hospital Purchasing Departments and Distributors and Any Other Stakeholders.” The EUA was reissued to clarify certain questions that arose after the initial issuance of the EUA.
• FDA published a fact sheet to provide information to the food and agriculture sector on the use of respirators, face masks, and cloth face coverings during the pandemic.
• FDA issued a statement on its efforts to ensure the availability of alcohol-based hand sanitizer during the COVID-19 pandemic. 

April 27, 2020

• FDA published an enforcement policy for remote digital pathology devices during the COVID-19 public health emergency.
• FDA issued a drug safety communication cautioning against the use of chloroquine or hydroxychloroquine to treat COVID-19 outside of the hospital setting or a clinical trial.
• FDA has now authorized the emergency use of eight diagnostic tests for coronavirus; three Emergency Use Authorizations (EUAs) were issued by FDA on April 24th.
• FDA and FTC issued a Warning Letter with respect to alleged false and misleading claims that a hand sanitizer is safe and/or effective for the treatment of COVID-19. 

April 24, 2020

• Congress passed a $484 billion coronavirus aid package on April 23rd.
• The United States District Court for the District of Maryland extended the deadline for the submission of pre-market applications by manufacturers of e-cigarettes, cigars, and other deemed new tobacco products. The pre-market submissions are now due to FDA on September 9, 2020. See FDA announcement here.
• FDA issued an enforcement policy for imaging systems during the COVID-19 pandemic.
• FDA issued an enforcement policy for non-invasive fetal and maternal monitoring devices used to support patient monitoring during the COVID-19 pandemic.
• FDA authorized the emergency use of a device to help treat lung failure caused by COVID 19. 

April 23, 2020

• FDA authorized the emergency use of Remote Patient Monitors and an Extracorporeal Blood Purification (EBP) Device.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that consumer products are safe and/or effective for the treatment of COVID-19.
• FDA issued a temporary policy on the repackaging or combining of propofol drug products during the COVID-19 pandemic.
• The House Energy and Commerce Committee held a teleconference with FDA Commissioner Stephen Hahn, M.D., for a briefing and discussion on the FDA’s response to the COVID-19 public health emergency. The Committee issued a Statement regarding this meeting. 

April 22, 2020

• FDA issued an Emergency Use Authorization (EUA) for a sterilizer to be used in decontaminating compatible N95 or N95-equivalent respirators for single-user reuse by healthcare providers.
• FDA’s Center for Devices and Radiological Health (CDRH) updated its EUA Interactive Review Template for ventilators, ventilator tubing connectors and ventilator accessories.
• FDA is hosting a Virtual Town Hall on diagnostic testing for clinical laboratories and commercial manufacturers that are developing or have developed diagnostic tests for COVID-19.

April 21, 2020

• FDA has re-issued an emergency use authorization, which now provides for the first COVID-19 test for patient at-home nasal swab sample collection. Patients self-swab to collect their nasal sample, and then they mail their sample, in an insulated package, to a LabCorp facility for testing. On March 16, 2020, FDA authorized the RT-PCR test for specimen collection from individuals by their healthcare provider, and this authorization is incorporated into the re-issued EUA.
• FDA issued an EUA for face masks in response to concerns about supply and availability of face masks for use by the general public, including healthcare personnel in healthcare settings as personal protective equipment (PPE). The EUA was not issued to a specific company but to “Manufacturers of Face Masks; Health Care Personnel; Hospital Purchasing Departments and Distributors; and Any Other Stakeholders.”
• FDA issued a temporary policy for the compounding of certain drugs for hospitalized patients by pharmacy compounders not registered as outsourcing facilities during the COVID-19 pandemic.
• FDA updated its policy for the temporary use of portable cryogenic containers not in compliance with 21 C.F.R. § 211.94(e)(1) for Oxygen and Nitrogen during the COVID-19 public health emergency.
• FDA provided an update about its Coronavirus Therapeutic Acceleration Program (CTAP). See Sidley CTAP description here.

April 20, 2020

• FDA issued a statement providing an update on serological test validation and education efforts. In this statement, FDA noted that it will collaborate with NIH’s National Cancer Institute (NCI), National Institute of Allergy and Infectious Disease (NIAID), and CDC to establish a capability at NIH to evaluate serological tests for developers.
• FDA published a letter to healthcare providers on the use of serological tests for COVID-19. FDA also published a fact sheet entitled “Serological Testing For Antibodies to SARS-CoV-2 Infections.”
• FDA authorized the emergency use of a device designed to reduce pathogens and inflammatory mediators in the bloodstream of confirmed COVID-19 adult patients admitted to an intensive care unit with imminent or confirmed respiratory failure.
• FDA continues to publish Emergency Use Authorizations here and has updated its FAQs on diagnostic testing.
• A federal judge in Florida issued a temporary injunction against Genesis II Church of Health and Healing and four individuals connected with it to prevent the sale of “Miracle Mineral Solution (MMS)” to treat, among other things, COVID-19. FDA and FTC previously issued a joint warning letter to Genesis II Church about the MMS products. A hearing to extend the injunction is scheduled for May 1, 2020.

April 17, 2020

• FDA announced a partnership with the Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton to address COVID-19 testing supply needs.
• FDA updated its guidance on the conduct of clinical trials of medical products during the COVID-19 public health emergency to include new information on conducting clinical trials remotely.
• FDA published an enforcement policy for telethermographic systems during the COVID-19 public health emergency.
• FDA Commissioner Stephen Hahn issued a statement that the agency is continuing user-fee review activities during the COVID-19 public health emergency and stating that “it is possible that we will not be able to sustain our current level of performance indefinitely.”
• FDA launched a new webpage to encourage fully recovered COVID-19 patients to donate their plasma at blood or plasma collection centers. The webpage also provides information for the general public to donate blood.
• FDA announced that the public meeting to discuss medical device user fee amendments (MDUFA) for fiscal years 2023-2027 would be postponed indefinitely. The meeting was originally scheduled for April 3rd, then rescheduled for May 5th.
• FDA issued a Warning Letter to a company offering chloroquine phosphate products for sale and issued another Warning Letter to a company that claimed, among other things, that its product had “anti-parasitic efficiency” comparable to chloroquine.

April 16, 2020

• FDA authorized the emergency use of two serology tests (Emergency Use Authorization [EUA] from Chembio Diagnostic Systems, Inc. here and EUA from Ortho-Clinical Diagnostics, Inc. here) to detect the presence of coronavirus antibodies.
• FDA authorized the emergency use of a sterilizer for use in decontaminating N95 and N95-equivalent respirators for healthcare personnel.
• FDA published a temporary policy for the compounding of certain drugs for hospitalized patients by outsourcing facilities during the COVID-19 pandemic.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that certain drugs and essential oils were safe and/or effective for the treatment of COVID-19.

April 15, 2020

• HHS published an advisory opinion setting forth its current views regarding immunity under the Public Readiness and Emergency Preparedness Act (PREP Act) during the COVID-19 public health emergency.
• FDA issued an enforcement policy for digital health devices for treating psychiatric disorders during the COVID-19 public health emergency.
• FDA will hold a virtual town hall on April 15th from 12:15-1:15 pm (EST) to answer technical questions about the development and validation of coronavirus diagnostic tests.
• FDA authorized the emergency use of a diaphragmatic pacing therapy system (DPTS) during the COVID-19 public health emergency. The DPTS is used to wean certain patients in healthcare settings off of ventilators.

April 14, 2020

• FDA announced that it is currently prioritizing the review of any newly submitted Abbreviated New Drug Applications (ANDAs) for chloroquine phosphate and hydroxychloroquine sulfate pursuant to its MAPP 5240.3: Prioritization of the Review of Original ANDAs, Amendments, and Supplements.
• FDA updated its Q&A For Consumers regarding hand sanitizers and COVID-19.
• FDA issued an Emergency Use Authorization (EUA) for an infusion pump for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with or suspected of having COVID-19 and to decrease the exposure of healthcare providers to such patients.
• FDA issued an EUA for CytoSorb, an extracorporeal blood purification device, to treat patients 18 or older with confirmed COVID-19 admitted to an intensive care unit with confirmed or imminent respiratory failure, to reduce pro-inflammatory cytokine levels.
• FDA and FTC issued a Warning Letter to a manufacturer of herbal products with respect to alleged false and misleading claims that certain of its products were safe and/or effective for the treatment of COVID-19.

April 13, 2020

• FDA issued two product-specific guidance documents to support the development of generic versions of chloroquine phosphate and hydroxychloroquine sulfate.
• FDA issued two Emergency Use Authorizations (EUAs) (see first sterilization system; second sterilization system) for sterilization systems to be used for the decontamination of certain respirators.
• FDA advised stakeholders not to use the antiparasitic drug ivermectin as a treatment for COVID-19 in humans.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that consumer products were safe and/or effective for the treatment of COVID-19.
• FDA’s Center for Devices and Radiological Health has updated its FAQs related to the performance and development of diagnostic testing for COVID-19.

April 10, 2020

• FDA issued an emergency use authorization (EUA) for an extracorporeal blood purification system to treat patients 18 years or older with COVID-19 admitted to intensive care with confirmed or imminent respiratory failure.
• FDA published temporary policy regarding non-standard Personal Protective Equipment (PPE) practices for sterile compounding by pharmacy compounders not registered as outsourcing facilities during the public health emergency.
• FDA issued a Constituent Update addressing safe food handling and employee health in retail food settings during the current public health emergency. FDA published a fact sheet detailing best practices for retail food stores, restaurants, and food pickup and delivery services during the COVID-19 pandemic.
• FDA updated information on the use of fecal microbiota transplantation (FMT) for investigational use, either under an Investigational New Drug Application (IND) or under FDA’s enforcement discretion policy, during the COVID-19 pandemic. In this update, the agency announced additional safety precautions regarding the use of FMT.

April 9, 2020

• FDA published guidance for industry on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency. FDA has not approved convalescent plasma and it remains an investigational product. The guidance also provides patient eligibility criteria and a framework for the collection and labeling of convalescent plasma.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that chlorine dioxide products are safe and/or effective for the treatment of COVID-19. FDA also issued a Consumer Alert on the issue.
• FDA posted a Question and Answer (Q&A) on Manufacturing and Supply Chain Change Requests.

April 8, 2020

• On April 7th, FDA Commissioner Dr. Stephen Hahn issued a statement on serological tests. Dr. Hahn noted that, to date, FDA has only authorized the emergency use of one serological test and cautioned that some firms are falsely claiming that their serological tests are FDA approved or authorized, or falsely claiming that they can diagnose COVID-19. Dr. Hahn noted that FDA will take appropriate action against firms making false claims or marketing tests that are not accurate and reliable.
• FDA approved an Abbreviated New Drug Application (ANDA) for hydroxychloroquine sulfate tablets USP indicated to treat: 1) certain types of uncomplicated malaria, 2) lupus in adults, and 3) acute and chronic rheumatoid arthritis in adults.
• FDA and FTC continue to issue Warning Letters with respect to alleged false and misleading claims that CBD products (see: National Roots Hemp and Indigo Naturals), herbal products, essential oils, and homeopathic drugs and dietary supplements were safe and/or effective for the treatment of COVID-19.
• FDA provided certain policy clarifications regarding the compounding of drugs during the pandemic.
• FEMA issued a temporary final rule that will allocate “certain scarce or threatened materials” for domestic use and will preclude those materials from being exported without explicit approval by the agency. The rule covers five types of PPE, including N95 respirators, other filtering facepiece respirators, elastomeric air-purifying respirators, PPE surgical masks, and PPE gloves or surgical gloves.

April 7, 2020

• FDA’s Center for Devices and Radiological Health (CDRH) held a Webinar for industry on the agency’s enforcement policy on personal protective equipment (PPE), including masks, respirators, gloves, and gowns. FDA also provided guidance on what information should be included in an Emergency Use Authorization (EUA) for decontaminants of face masks and respirators.
• FDA published guidance for extracorporeal membrane oxygenation (ECMO) and cardiopulmonary bypass (CPB) devices during the COVID-19 pandemic.
• FDA issued an enforcement policy for remote ophthalmic assessment and monitoring devices during the COVID-19 public health emergency.
• HHS’s Office of the Inspector General (OIG) released the results of a telephone survey, available here, of 323 hospitals across 46 States, D.C., and Puerto Rico. The survey found that there are “severe shortages of testing supplies and extended waits for test results.” Hospitals reported they were unable to keep up with testing demands because of lack of materials, and often had to wait seven days or longer for results. The survey was conducted from March 23 to 27, 2020.
• To date, FDA has authorized the emergency use of 29 in vitro diagnostic tests for COVID-19. FDA’s EUA page is here, and FDA’s updated FAQ on diagnostic testing is here.

April 6, 2020

• FDA revised its guidance on face masks and respirators during the COVID-19 pandemic, and posted answers to Frequently Asked Questions (FAQ) on the shortage of surgical masks and gowns, including KN95 masks from China. This follows FDA’s authorization of the emergency use for certain non-NIOSH-approved respirators made in China, which makes KN95 respirators eligible for authorization if certain criteria are met.
• FDA announced here, that it would facilitate the development of, and access to, two investigational therapies derived from human blood: convalescent plasma and hyperimmune globulin–antibody rich blood products made from blood donated by people who have recovered from coronavirus. FDA is working with the Mayo Clinic and the American Red Cross to conduct an expanded access program for the use of convalescent plasma in COVID-19 patients. A study of hyperimmune globulin will be conducted by the NIH’s National Institute of Allergy and Infectious Disease.
• FDA issued guidance on conducting and reviewing studies to support new animal drug development during the COVID-19 public health emergency. The guidance aims to help minimize the potential impact of COVID-19 on new animal drug development. FDA stated the guidance aligns with similar recommendations for sponsors of human drugs, biologics, and medical devices.
• FDA announced here that it would begin to request that importers send records required under the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) rule electronically.
• FDA published a guidance for infusion pumps and accessories during the COVID-19 pandemic, which provides flexibility for manufacturers of certain FDA-cleared infusion pumps and accessories to expand access to these products. 
• FDA issued new guidance on clinical electronic thermometers during the COVID-19 pandemic. This guidance allows manufacturers of certain clinical electronic thermometers to be distributed and used without meeting specific regulatory requirements. The guidance covers both contact and non-contact clinical thermometers.
• FDA’s Center for Radiological Health (CDRH) issued an updated letter to industry stating that in-person meetings would be converted to teleconferences though May 30, 2020. In addition, response due dates were extended by 90 days for marketing applications on hold as of March 16, 2020, where the response due date was on or before June 30, 2020.
• CDRH also issued recommendations for medical device manufacturers to reduce the risk of exposure to the virus that causes COVID-19 among manufacturing personnel.
• FDA has now authorized 28 EUAs for in vitro diagnostic tests, 4 EUAs for PPE, and 1 EUA for a ventilator. See FDA’s EUA webpage here.

April 3, 2020

• The White House issued Statement from the President regarding the Defense Production Act’s application to certain companies’ production of N-95 respirators. One such Memorandum on Order under the Defense Product Act states that it gives the Secretary of Homeland Security authority, through the FEMA Administrator, to use “any and all authority available under the Act to acquire, from any appropriate subsidiary or affiliate[s] … the number of N-95 respirators that the Administrator determines to be appropriate.”
• FDA authorized the emergency use of the first serology test that will test for the presence of coronavirus antibodies. The manufacturer of the test, Cellex Inc., notes that the results from the serology test should not be used as the sole basis of diagnosis. The test may only be used in laboratories certified under CLIA to perform moderate and high complexity tests. FDA’s EUA website is here and states that 25 EUAs for diagnostic tests have been issued to date.
• FDA updated policy to address the urgent need for blood during the public health emergency by making changes to three guidances and issuing one new guidance. First, FDA revised its 2015 guidance for reducing the risk of HIV transmission by blood and blood products by decreasing the deferral period for certain donors. Second, FDA revised its recommendations to reduce the risk of transfusion-transmitted malaria by decreasing the deferral period for those who had traveled to malaria-endemic areas. Third, FDA finalized a guidance to reduce the possible risk of transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by blood and blood components by eliminating certain the deferral periods. Finally, FDA issued guidance on alternative procedures for blood and blood components during the COVID-19 pandemic to allow certain temporary exceptions or alternatives to current regulatory requirements. FDA’s Press Release is here.
• FDA announced that almost 400 Commissioned Corps Officers have been deployed to aid in response to the Coronavirus public health emergency. The Corps deploy across the US to assist with COVID-19 screening at airports and other ports of entry. They serve on military installations and at local healthcare facilities to provide care and comfort to those in quarantine and isolation due to the virus. FDA Voice Article here.
• FDA and FTC continue to issue warning letters with respect to alleged false and misleading claims that colloidal silver, homeopathic drug products, and essential oils were safe and/or effective for the treatment of COVID-19.
• Frank Yiannis, Deputy Commissioner for Food Policy and Response at FDA, issued a food supply public service announcement found here, stating that the U.S. food supply remains safe for both humans and animals, and that FDA has no evidence of human or animal food or food packaging being associated with the transmission of COVID-19. He stated that there are no nationwide shortages of food, despite localized reports of shortages.
• FDA announced that its public meeting on the Medical Device User Fee Amendments (MDUFA) will be held virtually on May 5th, 2020. More information here.

April 2, 2020

• FDA issued guidance regarding nutrition labeling of standard menu items in chain restaurants and similar retail food establishments during the COVID-19 pandemic. This guidance provides temporary flexibility to these food establishments that are currently required to provide nutrition information, including calories, on menus and menu boards, as required by FDA regulations. This change reflects the rapid change of chain restaurants and similar retail establishments to a takeout only business. FDA will not object is establishments do not meet menu labeling requirements during this public health emergency. Constituent update here.
• FDA and FTC warned a NeuroXPF for the sale of certain cannabidiol (CBD) products intended to mitigate, prevent, treat, diagnose, or cure COVID-19. FDA determined that this product was an unapproved new drug in violation of FDCA Section 505(a), and also a misbranded drug in violation of FDCA Section 502. Warning Letter here.
• FDA, in collaboration with CDC and the Biodefense and Emerging Infections Research Resources Repository (BEI Resources), the Institute for Genome Sciences at the University of Maryland, and the National Center for Biotechnology Information (NCBI), developed quality controlled reference sequence data for the SARS-CoV-2 reference strain for the United States. The availability of this data will help test developers and vaccine developers expedite development of medical countermeasures and identify new or more stable targets for future tests. Website here.
• FDA added a footnote to its guidance on the compounding of hand sanitizer in response from pushback from pharmacists. The footnote would allow pharmacists to use food-grade alcohol, in place of the standard United States Pharmacopeia (USP) alcohol to compound hand sanitizer during the public health emergency. Article here.
• FDA hosted a Virtual Town Hall yesterday to answer technical questions from developers, manufacturers, and clinical laboratories on diagnostic testing for coronavirus. FDA reiterated its policy on the development and authorization of in vitro diagnostic tests and directed the audience to FDA’s recently updated Q&A on diagnostic testing. The majority of industry questions focused on serology testing, and FDA announced that a serology test may be authorized this week. FDA will be hosting Virtual Town Halls on diagnostic testing weekly.

April 1, 2020

• FDA announced a new program to expedite the development of potentially effective lifesaving treatments for Coronavirus called the Coronavirus Treatment Acceleration Program (CTAP). This program will use “every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus.” The Agency has redeployed medical and regulatory staff to serve on review teams for COVID-19 therapies, streamlined processes and operations for inquiries and requests from industry, and provided resources to healthcare providers and researchers to help them submit and use investigational products. Press release here and CTAP website here.
• FDA and FTC warned three companies for selling fraudulent products with claims to treat, prevent, diagnose, or cure coronavirus: Halosense Inc., Bioactive C60/FullerLifeC60 LLC, and JRB Enterprise Group Inc. dba Anti Aging Bed. The agency alleged products sold by each of these companies to be unapproved new drugs sold in violation of FDCA Section 505(a), and the products were misbranded drugs in violation of FDCA Section 502. All warning letters sent to fraudulent products with claims to treat, prevent, diagnose, mitigate, or cure COVID-19 can be found here.
• FDA posted information regarding shortages of two drugs authorized for the emergency treatment of COVID-19: hydroxychloroquine and chloroquine. The Agency stated it was working with manufacturers to assess supply and actively evaluating market demand for patients who are already dependent on the drugs as a malaria, lupus, or rheumatoid arthritis therapeutic. More information here.
• FDA issued two new EUAs for in vitro diagnostic tests to detect the novel coronavirus, bringing the total authorizations to 22. All EUAs can be found here. 

March 31, 2020

• Yesterday, FDA filed a motion with the U.S. District Court of Maryland requesting a 120-day extension of the premarket tobacco product application deadline, which is currently May 12, 2020. Update here.
• FDA issued an emergency use authorization for Chloroquine phosphate and hydroxychloroquine sulfate for the treatment of COVID-19 with certain specifications. Other EUAs for PPE, in vitro diagnostic tests, and other medical devices can be tracked here.
• FDA issued guidance for gowns, other apparel, and gloves addressing circumstances in which the agency does not intend to object to distribution during the COVID-19 pandemic.
• FDA updated its guidance on the conduct of clinical trials of medical products during the COVID-19 pandemic. The updated guidance now includes a Q&A for sponsors, investigators, and IRBs on various clinical trial considerations in light of COVID-19. For example, FDA answers how a sponsor should submit a change in protocol resulting from challenges due to the COVID-19 pandemic.
• The Agency discussed its role to expedite review of diagnostic tests to combat COVID-19 in a press announcement. FDA described its role as determining “if the tests developed by others provide accurate and reliable results, even when some would prefer that [the agency] let tests on the market without evidence that they work.” The statement provides an overview of how a test is developed and the timeline of FDA support for test developers.
• FDA provided an overview on the signing of the COVID-19 emergency relief bill, which included over-the-counter drug reform and user fee legislation. The legislation provides an additional $80 million in funding to FDA for COVID-19 response efforts, including the development of medical countermeasures and vaccines. The legislation also “reforms and modernizes the way certain over-the-counter (OTC) drugs are regulated in the United States—a landmark step that will have impact lasting long after the current public health emergency.” 

March 30, 2020

• FDA published an enforcement policy for sterilizers, disinfectant devices, and air purifiers during the COVID-19 public health emergency.
• FDA issued guidance to industry, including drug & biologic manufacturers, on notifying FDA of a permanent discontinuance or interruption in manufacturing that is likely to lead to meaningful disruptions in supply, pursuant to section 506C of the Federal Food, Drug, and Cosmetic Act. The guidance requests that applicants and manufacturers provide additional details and follow addition procedures to ensure that FDA has the specific information it needs to help prevent or mitigate shortages.
• FDA explained that it is partnering with the Federal Emergency Management Agency (FEMA) on supply issues, including the importation of needed medical products to support U.S. response to COVID-19. The announcement focused on FDA’s efforts, including reaching out directly to industry, to mitigate supply interruptions of medical devices, including PPE, human and animal therapeutics, blood supply, and human and animal food. FDA's announcement here.
• FDA, with the Federal Trade Commission, issued warning letters to two companies regarding claims made in COVID-19 related products. One company sold “infection prevention nasal sprays” (Warning Letter here) and the other sold herbal products (Warning Letter here).
• FDA updated its Q&A on food safety during the Coronavirus pandemic and stated that there are no current nationwide food shortages. Consumer update here.
• FDA published a Letter to Stakeholders warning consumers not to use chloroquine phosphate intended for fish as treatment for COVID-19 in humans. The Center for Veterinary Medicine (CVM) stated that humans should not take any form of chloroquine unless it has been prescribed by a licensed healthcare professional and obtained from a legitimate source.
• FDA issued an Emergency Use Authorization (EUA) to allow for the emergency use in healthcare settings of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators. FDA also updated an EUA for certain imported non-NIOSH-approved respirators that have been designed, evaluated and validated to meet performance standards articulated in the EUA. To date, three EUAs, including one for a decontamination system, have been authorized for PPE and nineteen for in vitro diagnostic tests. Press release here. See also FDA’s EUA page here. 

March 27, 2020

• FDA issued guidance on nutrition labeling of certain packaged food during the COVID-19 pandemic. This guidance provides restaurants and food manufacturers with certain flexibility regarding nutrition labeling during the public health emergency. Update here.
• FDA published a Q&A for Consumers about hand sanitizer and COVID-19. The Q&A cites the three guidance documents published this week pertaining to FDA’s policy on the manufacture, preparation, and compounding of certain alcohol-based hand sanitizer during the Coronavirus pandemic.
• FDA issued an enforcement policy for face masks and respirators during the Coronavirus Disease (COVID-19) public health emergency. FDA does not intend to object to individuals’ distribution and use of improvised PPE when no alternatives, such as FDA-cleared masks or respirators, are available. See article here.
• FDA shared FAQs on 3D Printing of Medical Devices, Accessories, Components, and Parts During the COVID-19 Pandemic. The agency stated that while it is possible to use 3D printing to make certain PPE, there are technical challenges that have to be overcome, including whether 3D-printed PPE can provide the same fluid barrier and air filtration protection as FDA-cleared surgical masks and N95 respirators.
• The Coronavirus Relief Bill, which is expected to pass the House on March 27, includes an OTC Drug User Free Program, which would ensure FDA can approve OTC medicines without going through a full notice and comment rulemaking. Article here and overview of Bill here.
• A current list of all Emergency Use Authorizations (EUAs) can be found here. This week, FDA has authorized emergency use of ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, as well as imported, non-NIOSH approved disposable filtering facepiece respirators. As of March 26, FDA has approved 18 in vitro diagnostic test EUAs to detect coronavirus.

March 26, 2020

• On March 25, HHS declared that “circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.” Public Inspection notice here.
• FDA authorized the emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories that FDA determines meet the criteria for safety, performance and labeling.
• FDA issued Guidance for the manufacture of alcohol for incorporation into alcohol-based hand sanitizer products during the COVID-19 public health emergency.
• Yesterday, HHS declared that “circumstances exist justifying the authorization of emergency use of medical devices, including alternative products used as medical devices, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.” Public Inspection notice here.
• FDA authorized the emergency use of certain ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors, and ventilator accessories that FDA determines meet the criteria for safety, performance and labeling.
• FDA issued Guidance for the manufacture of alcohol for incorporation into alcohol-based hand sanitizer products during the public health emergency (COVID-19).
• FDA published a temporary policy on compounding by outsourcing facilities registered under FDCA 503B using bulk drug substances.

March 25, 2020

• FDA-CDRH issued a letter to medical device establishments on the steps it is taking to address the impact of the COVID-19 on the CDRH’s day-to-day operations, including the processing of incoming documents and an overview of how to submit an inquiry or request for an Emergency Use Authorization.
• U.S. Customs and Border Patrol provided instructions to manufacturers regarding importing Personal Protective Equipment (PPE) and certain other devices. FDA also issued a press release describing its actions to facilitate the importation of PPE and other devices.
• FDA-CVM published an enforcement policy addressing veterinarians’ ability to provide veterinary medical services during the COVID-19 pandemic.

March 24, 2020

• FDA announced that it would collaborate with the European Medicines Agency (EMA) to facilitate vaccine development for the coronavirus. The EMA and FDA jointly chaired the first global regulators meeting to discuss regulatory strategies related to vaccine development. The meeting included representatives from 25 public health agencies and the World Health Organization.
• FDA issued a safety alert regarding the clinical use of fecal microbiota for transplantation and additional related safety precautions during the COVID-19 pandemic.
• FDA announced that Gilead’s antiviral product remdesivir received Orphan Drug Designation to treat COVID-19.

March 23, 2020

• FDA issued a policy regarding certain REMs-required laboratory testing and imaging studies during the coronavirus pandemic.
• FDA issued an enforcement policy to address the availability of ventilators and other respiratory devices during the coronavirus pandemic.
• FDA issued a letter to healthcare providers about conservation strategies for surgical gloves, in light of the potential for the need for Personal Protective Equipment (PPE) to outpace available supply.

March 21, 2020

• The Department of Homeland Security’s Cyber Infrastructure Division issued guidance on identifying critical infrastructure during COVID-19. The guidance states that it is intended to support State, Local, and industry partners in identifying the critical infrastructure sectors and the essential workers needed to maintain the services and functions needed during the pandemic response.
• FDA released a second guidance related to the production of alcohol-based hand sanitizer.
• FDA issued an enforcement policy to help expand the availability and capability of non-invasive remote monitoring devices used to support patient monitoring during the coronavirus pandemic.
• FDA warned the public about fraudulent and unauthorized COVID-19 test kits that are being sold directly to consumers. Press release here.

March 20, 2020

• FDA issued a statement advising patients on the use of non-steroidal anti-inflammatory drugs (NSAIDs) for COVID-19.
• FDA issued guidance to industry on postmarketing adverse event reporting for medical products and dietary supplements during the COVID-19 pandemic.

March 19, 2020

• FDA announced that it would temporarily postpone all domestic routine surveillance facility inspections and that all domestic for-cause inspections will proceed if deemed mission-critical and if safe for all involved.
• The President signed an Executive Order on prioritizing and allocating health and medical resources – including personal protective equipment, ventilators and other supplies – to respond to the spread of COVID-19 under Defense Production Act and other laws.
• FDA issued a press release encouraging blood donation at blood donation centers.

March 18, 2020

• FDA announced temporary policy for Food Safety and Modernization Act on site audit requirements “to minimize disruptions so that the food industry can meet the demand while also continuing to conduct supplier verification activities that are designed to ensure food safety and following government travel restrictions and advisories.”
• FDA announced that all public meetings with CDER through April 30th would be postponed, cancelled, or modified to take place remotely.

March 17, 2020

• FDA updated its policy relating to diagnostic testing for COVID-19 for clinical laboratories and commercial manufacturers, stating that this effort is designed to accelerate the availability of such diagnostic tests during the public health emergency.

February 4, 2021

• The EMA has updated its guidance on conducting clinical trials during the COVID-19 pandemic. The main change relates to remote source data verification (remote SDV). Previously, remote SDV would be appropriate only in ‘very few trials’ but the latest edition explains that remote SDV may be considered where: (i) the trial involves COVID-19 treatment or prevention; (ii) the trial is investigating a serious or life-threatening condition; (iii) the absence of SDV for critical data may pose unacceptable risks to participants' safety or to the reliability or integrity of the trial results; (iv) the trial involves particularly vulnerable participants such as children or participants who are temporarily or permanently incapable of giving their informed consent; (v) trials are regarded as pivotal. However, remote SDV can only be carried out with agreement from the clinical trial investigators and remote SDV should not be adopted unless adequate data protection, including data security and protection of personal data even if pseudonymised, is ensured. See the updated guidance here.

• The EMA’s CHMP is reviewing available data on the use of the monoclonal antibodies casirivimab, imdevimab, bamlanivimab and etesevimab to treat patients with COVID-19 who do not require oxygen supplementation and who are at high risk of progressing to severe COVID-19. See the press release here.

• The EMA has announced its new pilot project ‘OPEN’ which started in December to increase international collaboration on the evaluation of COVID-19 vaccines and therapeutics. Regulators from Australia, Canada, Japan, Switzerland and the World Health Organization (WHO) are participating in the pilot under the terms of existing confidentiality arrangements. The collaboration allows sharing of expertise during the evaluation of COVID-19 vaccines and therapeutics. See the press release here.

February 3, 2021

• The EMA’s CHMP has started a rolling review of NVX-CoV2373, a COVID‑19 vaccine being developed by Novavax CZ AS (a subsidiary of Novavax, Inc.) which will continue until enough evidence is available for a formal marketing authorisation application. See the press release here.

January 29, 2021

• From January 30, 2021 until March 31, 2021 exports of COVID-19 vaccines covered by Advance Purchase Agreement with the EU will be subject to an early notification and authorisation by Member States before they are exported outside the EU. This temporary export transparency and export authorisation mechanism has been adopted on the basis of Regulation 2015/479 on common rules for exports. The aim of this measure is to ensure timely access to COVID-19 vaccines for EU citizens and to tackle the current lack of transparency. The Commission will ensure that the Ireland/Northern Ireland Protocol is unaffected and is not triggering the safeguard clause. See the press release here and the Q&A document here.

January 28,  2021

• The European Commission has announced that it has prolonged the State aid Temporary Framework until December 31, 2021. Additionally, the Commission has expanded its scope by increasing the ceilings set out in it and by allowing the conversion of certain repayable instruments into direct grants until the end of next year. See the press release here.

January 21, 2021 

• The European Commission has sent a draft proposal to further prolong the State aid Temporary Framework until December 31, 2021 and to further adjust is scope to Member States for consultation. See the press release here.
• EU Member States have unanimously agreed, by written procedure, on a European Council recommendation setting a common framework for the use of rapid antigen tests and the mutual recognition of COVID-19 test results across the EU. The recommendation includes the validation and mutual recognition of rapid antigen tests and RT-PCR tests among member states, the sharing of a standardised set of data (through a digital platform), the development of a common list of COVID-19 rapid antigen tests, the prioritisation of situations for the use of such tests (e.g. contacts of confirmed cases, outbreak clusters). See the press release here.

January 12, 2021

• The EMA has received an application for conditional marketing authorisation for a COVID-19 vaccine developed by AstraZeneca and Oxford University. The assessment of the vaccine will proceed under an accelerated timeline. An opinion on the marketing authorisation could be issued by January 29. This short timeframe is only possible because the EMA has already reviewed some data on the vaccine during a rolling review. See the press release here.
• The European Commission has concluded explanatory talks with Valneva with a view to purchasing its potential COVID-19 vaccine. The envisaged contract provides for the possibility for all EU Member States to purchase together 30 million doses, and they could further purchase up to 30 million more doses. See the press release here.

January 11, 2021

• In response to the exceptional circumstances of the COVID-19 pandemic, the European Commission has published an informational notice which confirms that Notified Bodies may temporarily take extraordinary measures, in specific cases, including remote audits of manufacturers’ quality management systems under the IVDR/MDR where this is justified. These temporary extraordinary measures will only be used until on-site audits are possible again and the Commission has invited all Member States to systematically notify the use of temporary extraordinary measures. See the informational notice here.
• The European Commission has selected 24 projects that will build new programmes, or expand existing ones, for the collection of plasma from donors recovered from COVID-19 which will be used for the treatment of patients with COVID-19. This action is financed through the Emergency Support Instrument, for a total of €36 million. See the press release here.
• The European Commission has announced that Belgium, the Netherlands and Slovenia will become new host countries for rescEU medical supplies. In addition, a second medical reserve will be hosted by Germany. See the press release here.

January 6, 2021

• The European Commission has granted a conditional marketing authorisation to the COVID-19 vaccine being developed by Moderna Biotech Spain, S.L. This is the second COVID-19 vaccine to be authorised for use in the EU. See the press release here.

December 7, 2020

• The European Council has adopted a Council Directive amending Council Directive 2006/112/EC which will enable Member States to relieve EU hospitals, medical practitioners and individuals of Value-Added Tax (VAT) when acquiring coronavirus vaccines and testing kits. Currently, Member States can apply reduced VAT rates on sales of vaccines but cannot apply a zero rate, while testing kits cannot benefit from reduced rates; under the amended Directive, Member States will be able to apply either reduced or zero rates to both vaccines and testing kits if they so choose. The measures approved only concern COVID-19 vaccines authorised by the European Commission or by the member states and COVID-19 test kits that comply with the applicable EU legislation. See the press release here.
• The Commission's Joint Research Centre has released two new reference materials, which they have developed as quality assurance tools for COVID-19 antibody tests. The reference materials enable laboratories to check whether the antibody tests in use are functioning correctly; the reference materials are also a first step in ensuring that the results obtained with various tests are comparable, and they can also support research on immunity against the virus and help monitor the efficiency of experimental vaccines. See the press release here.

December 1, 2020

• The EMA has received an application for conditional marketing authorisation (CMA) for a COVID-19 mRNA vaccine by Moderna Biotech Spain, S.L. The assessment of the vaccine will proceed under an accelerated timeline. See the press release here.

November 17, 2020

• The Commission has approved a fifth contract to ensure access to a potential COVID-19 vaccine with CureVac. The contract provides for the initial purchase of 225 million doses on behalf of all EU Member States, plus an option to request up to a further 180 million doses, to be supplied once a vaccine has proven to be safe and effective against COVID-19. See the press release here.

November 16, 2020

• The CHMP has started a rolling review of data on a COVID-19 vaccine  known as mRNA-1273, which is being developed by Moderna Biotech Spain, S.L. (a subsidiary of Moderna, Inc.). See the press release here.

November 13, 2020

• The Commission has held the first meeting of the EU COVID-19 national scientific advice platform between Member States’ COVID-19 scientific advisors. The platform will facilitate more co-ordinated scientific advice on the approach to Member State COVID-19 public health measures across the EU. See the press release here.
• Due to liquidity shortages linked to the COVID-19 pandemic, the Commission has approved, under the state aid rules, €6.5 million to InnoGenerics to ensure that it has sufficient liquidity to resume, maintain and develop the activities of the production plant of generic drugs Apotex Leiden. See the press release here.
• The Commission has signed a grant of €1m, under the Emergency Support Instrument, to support the conduct of a clinical trial using Raloxifene for patients suffering from COVID-19. See the press release here.
• The EMA has published a safety monitoring plan for COVID-19 vaccines . The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed. The safety of COVID-19 vaccines will be monitored according to the guidance set out by EMA and NCAs in the good pharmacovigilance practices (GVP); specific guidance on the Pharmacovigilance Plan of the EU Regulatory Network for COVID-19 Vaccines can be found here.  In view of the extraordinary circumstances, though, EU authorities have planned several activities that will apply specifically to COVID-19 vaccines. See the press release here.
• The EMA has published guidance to support pharmaceutical companies’ preparation of risk management plans (RMPs) for COVID-19 vaccines.
• The Commission has approved the modification of four operational programmes in Spain, that will allow the mobilisation of more than €1.11 billion of the European Regional Development Fund (ERDF) to tackle the COVID-19 crisis. Among other things, this additional support will help: (i) increase the response capacity of the health system through the purchase of protective equipment and health material; (ii) alleviate the impact of the outbreak on the health system; (iii) engage additional healthcare staff; and (iv) the purchase and construction of new laboratory equipment for COVID-19 testing. See the press release here.

November 12, 2020

• The EU has announced that it will increase its contribution to COVAX to €500 million to secure global access to the COVID-19 vaccine. See the press release here.

November 11, 2020

• The EIB group has approved €400 million for the international COVAX initiative to ensure global access to the COVID-19 vaccine, and the EIB has approved € 1.8 billion for medical research, new hospitals and public health investment and local lending schemes to strengthen private sector reliance to the economic shocks of COVID-19. See the press release here.
• The Commission has taken the first steps towards building the European Health Union. The Commission has put forward a set of proposals to strengthen the EU's health security framework, and to reinforce the crisis preparedness and response role of key EU agencies. The aim is to ensure more co-ordination at EU level in order to step up the fight against the COVID-19 pandemic and future health emergencies. See the press release here. The Commission has also published a Q&A document.

November 6, 2020

• The International Coalition of Medicines (ICMRA) and the World Health Organization (WHO) have committed to working together to ensure that patients have access to safe and effective medicines against COVID-19 as early as possible, while the existing rigorous scientific standards for the evaluation and safety monitoring of treatments and vaccines are maintained at all times. See the press release here.
• The Commission has signed grant agreements, under Horizon 2020, with 23 new research projects to address the pressing needs of the COVID-19 pandemic. The funding will enable additional research to strengthen and adapt industrial capacity to manufacture and deploy medical equipment, such as ventilators; prevent and treat the coronavirus; develop medical technologies and digital tools, such as portable diagnostic systems; understand better the societal impact of the pandemic, for example on vulnerable and marginalised groups; and learn from large groups of patients (cohorts) across Europe in order to improve treatments. See the press release here.

November 5, 2020

• The Commission has announced the launch of its Intelligent Internet of Things (IntellloT) consortium which will focus its efforts on improving digital healthcare solutions and helping ease pressure on hospitals in light of the increasing rate of COVID-19 infections. The project will receive €8m in funding and will be comprised of 13 partners from 9 countries. See the press release here.

October 30, 2020

• The EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing (i) the clinical data in support of the authorisation of Veklury (remdesivir); and (ii) information on the COVID-19 treatments and vaccines that have received scientific advice or informal guidance from EMA’s pandemic Task Force (COVID-ETF). See the press release here.
• The EMA has updated its guidance for marketing authorisation holders on how to submit COVID-19-related individual case safety reports (ICSR) to EudraVigilance to acknowledge that COVID-19 related terms are made available from the updated Medical Dictionary for Regulatory Activities (MedDRA) version 23.0 onwards and to notify the release of a COVID-19 SMQ (Special MedDRA Query) with MedDRA version 23.1.

October 28, 2020

• The European Commission has adopted a Communication on additional COVID-19 response measures to reinforce the EU’s response to the resurgence in COVID-19 cases. The Communication sets out next steps in key areas, including, establishing more effective and rapid testing, making full use of contact tracing and warning apps across borders, and effective vaccination. See the press release here.

October 23, 2020

• The EMA has announced that it co-chaired a workshop convened by the International Coalition of Medicines Regulatory Authorities (ICMRA) to discuss the experiences of regulators in using real-world evidence and observational studies in the assessment of COVID-19 therapeutics and vaccines. See the press release here. The outcomes of these discussions are highlighted in a summary report that has been published by the ICMRA.

October 20, 2020

• The European Investment Bank (EIB) has signed a financing agreement to provide Atriva Therapeutics with €24 million for the research, development and clinical testing of the company’s lead product candidate against influenza and COVID-19; the EIB venture debt transaction will be financed under the Infectious Diseases Finance Facility set up as part of Horizon 2020. See the press release here.

October 19, 2020

• The European Commission’s interoperability gateway service for national contract tracing apps has gone live following a successful pilot phase and the first national apps have been linked through this service (Germany’s Corona-Warn-App, Ireland’s COVID tracker, and Italy’s immuni). See the press release here.

October 19, 2020

• The European Commission has published a Q&A document on the EU interoperability gateway for contract tracing and warning apps. The Q&A document covers the following aspects of the EU interoperability gateway: Using coronavirus tracing and warning apps, what it means if you receive a contact alert, how coronavirus tracing and warning apps work across borders, addressing concerns about privacy and security, and app usage information. See the press release here.

October 15, 2020

• The European Commission has listed key steps for Member States to take to ensure effective COVID-19 vaccination strategies and vaccines deployment in order to prepare the EU and its citizens for when a safe and effective vaccine is available, as well as priority groups to consider for vaccination first. See the press release here.

October 14, 2020

• The Committee on the Environment, Public Health and Food Safety (the ENVI Committee) has adopted its report on the programme for the EU's action in the health sector (the ‘EU4Health Programme’) with 74 votes to 5 and 1 abstention. MEPs want to raise the budget for the programme to €9.4 billion, as originally proposed by the Commission, to enhance health promotion and make health systems more resilient across the EU in light of the COVID-19 pandemic. See the press release here.

October 12, 2020

• The European Commission has proposed financial assistance of more than €132.7 million as advance payment to Germany, Ireland, Greece, Spain, Croatia, Hungary and Portugal following their request for assistance to address the coronavirus outbreak and its effects. This is part of an aid package of €823 million proposed under the EU Solidarity Fund. See the press release here.

October 8, 2020

• The Commission has signed a joint procurement contract with Gilead for the supply of up to 500,000 treatment courses of Veklury (remdesivir), and the opportunity to increase supply beyond the 500,000 treatment courses. See the press release here.

October 6, 2020

• The European Commission has announced a €150m financial contribution to the Venture Centre of Excellence (VCoE) programme. VCoE is a first of its kind open innovation platform in the Life Science sector in Europe aimed at fostering collaboration and investment sharing between the venture capital industry and corporates to boost investments in highly innovative digital health and life science start-ups. The European Commission is contributing €150m because the COVID-19 crisis has shown that strong partnerships are key to developing solutions for global healthcare challenges, and it has accelerated the digital transformation of healthcare in Europe. See the press release here.

October 5, 2020

• In an open letter sent to European Ombudsman Emily O’Reilly in response to an enquiry on the role of the EMA and its pandemic task force during the COVID-19 crisis, the EMA has reaffirmed that it will fully uphold transparency and independence standards in its evaluation of COVID-19 treatments and vaccines. The EMA explained that it is applying the same independence measures to its experts dealing with COVID-19 treatments and vaccines as it does for those dealing with all medicines, and that the EMA will publish the clinical data underpinning its recommendations for all COVID-19 medicines. See the press release here.

October 2, 2020

• The EMA’s safety committee (PRAC) has started a review of a safety signal to assess reports of acute kidney injury in some patients with COVID-19 taking Veklury (remdesivir).
• The European Commission has sent to Member States for consultation a draft proposal to prolong the State Aid Temporary Framework until 30 June 2021 and to adjust its scope. See the press release here.
• The European Commission has approved an extension of a Hungarian aid scheme to support research and development and production of coronavirus-relevant products. This extension makes available an additional budget of around €100 million (HUF 35 billion) that will be co-financed by the European Structural and Investment Funds, for a total budget of around €243 million (HUF 85 billion) including the initial scheme. See the press release here.

October 1, 2020

• The EMA’s Human Medicines Committee (CHMP) has started the first rolling review of a COVID-19 vaccine in the EU, which is being developed by AstraZeneca in collaboration with the University of Oxford. See the press release here.

September 29, 2020

• European Commission approves €2.2 million Belgian aid measures to support Flemish airports in the context of the coronavirus outbreak. See the press release here.
• The EU and Georgia sign Financing Agreements for COVID-19 recovery worth €129 million. See the press release here.

September 28, 2020

• The European Commission has confirmed the labelling and packaging flexibilities for COVID-19 vaccines following the endorsement of a memorandum of understanding on the matter among Member States and Heads of Medicines Agencies. The flexibilities being allowed include the alleviation of some of the language requirements, the acceptability of multi-dose presentations, the possibility of separate distribution of a print out of the package leaflets to accommodate for one patient leaflet per dose and for the accelerated availability of the vaccine, and the omission of country specific blue box requirements.

September 24, 2020

• The European Commission has published a Q&A document on the EU vaccines strategy. See the press release here.

September 22, 2020

• The European Parliament Committee on the Environment, Public Health and Food Safety (the ENVI Committee), as well as the Committee on Industry, Research and Energy, has debated ways to secure a quick and safe supply of COVID-19 vaccines, with representatives of pharmaceutical companies, research, civil society organisations and the EMA. See the press release here.
• Denmark, Greece, Hungary and Sweden have joined Germany and Romania as host states of the rescEU medical equipment reserve. With financial support from the European Commission, these six EU Member States will build up common European stocks of lifesaving protective and other vital medical equipment that can be distributed across Europe if national health systems become overwhelmed by COVID-19 patients. See the press release here.

September 18, 2020

• The European Commission has published recommendations for a common EU testing approach for COVID-19. See the press release here.
• The CHMP (the EMA’s drug evaluation committee) has given an opinion endorsing the use of dexamethasone as a treatment option for hospitalized COVID-19 patients who require oxygen therapy. See the press release here.
• The Commission has confirmed its participation in the COVID-19 Global Access Facility (COVAX) for equitable access to affordable COVID-19 vaccines and will contribute €400 million. See the press release here.
• The EU has announced that it will provide €150 million to 18 Member States for the transport of essential medical items, through the Emergency Support Instrument. See the press release here.
• The EMA, the Commission and the Heads of Medicines Agencies (HMA) have updated the Business Continuity Plan to cover pharmacovigilance and inspection procedures.

September 17, 2020

• The EMA has clarified that the suspension of the publication of clinical data does not apply to COVID-19 related products, in line with the EMA’s exceptional transparency measures for treatments and vaccines for COVID-19.
• The European Parliament Committee on the Environment, Public Health and Food Safety (the ENVI Committee) has called for common definitions and health criteria, and for the harmonisation of the methodology used to collect and evaluate the number of infected people. The European Parliament has also asked the Commission to develop a harmonised passenger locator form to build trust in an EU-wide monitoring system, and for the use of tracing apps to be encouraged. See the press release here.
• The European Parliament Committee on the Environment, Public Health and Food Safety (the ENVI Committee) has called for domestic production of essential and strategic medicines to be boosted because currently 40% of medicines marketed in the EU originate in non-EU countries. The European Parliament has also called for better co-ordination with and between EU countries, such as sharing best practices in stock management and creating co-ordinated health strategies. See the press release here.

September 14, 2020

• The Commission has started testing the interoperability gateway service for national contract tracing and warning apps. It kicked off test runs between the backend servers of the official apps from the Czech Republic, Denmark, Germany, Ireland, Italy and Latvia, and a newly established gateway server. See the press release here.

September 11, 2020

• The Council of the EU has approved a budget increase to the EU 2020 budget of €6.2 billion to address the impact of COVID-19 and to fund the vaccine strategy. Payments for the Emergency Support Instrument will increase by €1.09 billion, which will be used by the Commission as a down-payment for pre-ordering vaccine doses. See the press release here.
• The Commission has announced that it will provide €4 million for SUPPORT-E from its Horizon 2020 research and innovation programme. SUPPORT-E will support and co-ordinate efforts to determine if COVID-19 convalescent plasma transfusion is an effective and safe treatment. See the press release here.

September 10, 2020

• The Commission and WHO launched the High Level Facilitation Council. The Facilitation Council will lead the work of the global collaborative framework Access to COVID-19 Tools Accelerator (the ACT-A) to speed up the development and deployment of vaccines, tests and treatments against COVID-19, as well as to improve health systems. See the press release here.

September 9, 2020

• The Commission has concluded explanatory talks with a sixth manufacturer to purchase a potential vaccine against COVID-19. See the press release here.

September 8, 2020

• Companies developing and manufacturing COVID-19 vaccines will be liable according to current law. The European Parliament Committee on the Environment, Public Health and Food Safety (the ENVI Committee) calls for safe vaccines and full transparency in order to achieve trust in future COVID-19 vaccines. See the full update here.

September 3, 2020

• The European Parliament Committee on the Environment, Public Health and Food Safety (the ENVI Committee) has called for revision of the EU Civil Protection Mechanism (UCPM) so that it can better respond to large-scale emergencies such as COVID-19. Under UCPM, specifically through RescEU, medical equipment such as PPE, vaccines and therapeutics and laboratory supplies have been procured to support national health services during the pandemic. MEPs argue that RescEU must be strengthened to help the EU secure these critical supplies in future large-scale emergencies. See the press release here.

September 2, 2020

• The EU Committee for Environment, Public Health and Food Safety (‘ECDC’) has stated that EU countries should harmonise testing procedures and frequency, and that a stronger role for the ECDC is required which would allow it to issue recommendations. See the press release here.
• The EMA announced that it has finalised 17 scientific advice procedures for potential medicines to treat COVID-19, with a further 22 ongoing. It has been in contact with the developers of 158 potential COVID-19 treatments and 38 potential COVID-19 vaccines.
• The EMA has announced that on 31 August 2020 the CHMP started an evaluation of Dexamethasone Taw for a marketing authorisation. The CHMP is assessing the application under the minimum timeframe necessary to allow for a thorough evaluation of the medicine’s benefits and risks. As part of its evaluation, the CHMP will consider the outcome of its ongoing review of the use of dexamethasone to treat COVID-19. 

August 31, 2020

• The European Commission has joined the COVID-19 Vaccine Global Access Facility (COVAX). The COVAX Facility, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access for every country in the world. The Commission intends to mobilise up to €400 million in guarantees to support COVAX and its underlying objectives. See the press release here.

August 21, 2020

• The European Commission has decided to register a European Citizens’ Initiative (ECI) entitled ‘Right to Cure’. The organisers of the ECI call on the EU to, inter alia, ensure that IP rights, including patents, do not hamper the availability of any future COVID-19 vaccine or treatment, and to introduce legal obligations for beneficiaries from EU funds to share COVID-19 health technology related knowledge, IP and / or data in a technology or patent pool. The Commission has not analysed the substance of the ECI at this stage. Should the ECI receive 1 million statements of support within 1 year from at least 7 different Member States, the Commission will be required to respond. See the press release here.

August 13, 2020

• The European Commission has announced that 23 new COVID-19 research projects are to receive €128 million in funding under Horizon 2020. The 23 projects shortlisted for funding involve 347 research teams from 40 countries, including 34 participants from 16 countries outside of the EU.

August 11, 2020

• The European Commission has approved a HUF 50 billion (approximately €143 million) Hungarian aid scheme under the State Aid Temporary Framework. The aim of the scheme is to enhance and accelerate the development and production of COVID-19-relevant products, including vaccines, hospital and medical equipment, medicines, and the development of innovative processes for their efficient production. See the news update here.

July 31, 2020

• The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a report on the third global regulatory workshop on COVID-19 real world evidence and observational studies. The report notes that progress is being made on developing a pharmacovigilance network for vaccines, carrying out research in pregnant women and the establishment of international patient cohorts. See the EMA press release here.
• The EMA has announced that it has finalised 17 scientific advice procedures for potential medicines to treat COVID-19, with a further procedures 15 ongoing. The EMA has also been in contact with the developers of 154 potential COVID-19 treatments and 38 potential COVID-19 vaccines. See the EMA webpage on treatments and vaccines for COVID-19 here.
• The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a report on the second global regulatory workshop on COVID-19 therapeutics and clinical trials. The report notes that global regulatory authorities are receiving numerous proposals for phase 3 clinical trials from developers of COVID-19 treatments. ICMRA members have agreed on acceptable clinical-trial endpoints to facilitate rapid and consistent research. See the EMA press release here.
• The European Commission has invited more than 200 blood-collection services around the EU to apply for funding for the purchase of plasmapheresis equipment, i.e. equipment that takes plasma from donors. The aim of this action is to support the treatment of new COVID-19 patients who are fighting the disease, by increasing EU capacity to collect convalescent plasma, i.e. plasma from recovered COVID-19 patients. See the press release here.

July 24, 2020

• The EMA has commenced a review of dexamethasone for treating adults with COVID-19 requiring respiratory support. The review follows research by the RECOVERY study arm. See the press release here.

July 23, 2020

• The European Commission has published Guidelines on conformity assessment procedures for protective equipment. The Guidelines are addressed to prospective manufacturers and specify that the majority of protective equipment products, including FFP-type masks, are considered PPE. Other products, such as medical gloves and face masks, fall within the scope of the framework on medical devices.

July 21, 2020

• The EMA is applying exceptional transparency measures for treatments and vaccines against COVID-19 that are approved or under evaluation. The EMA intends to achieve this by shortening its standard publishing timeframes and publishing information it does not normally publish for other medicines. See the latest guidance here.
• The EMA has completed its infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. The final contract to be signed was with Utrecht University to study the impact of COVID-19 infection and medicines in pregnancy. See the press release here.

July 16, 2020

• On 13 July, the European Commission announced that it has approved a €80 million Slovak scheme intended to enhance and accelerate the development and production of products directly relevant to the COVID-19 outbreak, including vaccines, hospital and medical equipment, medicinal products and PPE. The scheme was approved under the State aid Temporary Framework.
• The CMDh has issued templates to support its updated practical guidance on how procedures will operate during the COVID-19 pandemic: (1) a template for submission of an application for a COVID-19 exceptional change management process (ECMP); and (2) a template for Step 3 (a notification of implementation of an ECMP). The CMDh notes that these documents supplement the more general guidance on regulatory flexibilities published by the European Commission. See the CMDh guidance and templates here.

July 15, 2020

• The European Commission has presented a communication on immediate short term measures intended to strengthen EU health preparedness for COVID-19 outbreaks. The communication lays out a number of priority areas, including: (i) increased testing coverage, contact tracing and surveillance; (ii) ensuring the smooth supply of PPE, medicines and medical devices through mechanisms such as emergency joint procurements and strategic EU stockpiles; (iii) maintaining rapid access to public health surge capacities; (iv) provision of targeted and localised non-pharmaceutical measures; (v) supporting vulnerable groups; and (vi) reducing the burden of seasonal flu. See the press release here.

July 14, 2020

• The EMA has urged researchers to adhere to the latest revision of the ENCePP Guide on methodological standards in pharmacoepidemiology. The foreword highlights chapters relevant to COVID-19 and examples of good practice./p>
• The EMA has announced that it has finalised 9 scientific procedures for potential medicines to treat COVID-19, with a further 13 ongoing. It has also been in contact with the developers of 148 potential COVID-19 treatments and 36 potential COVID-19 vaccines.
• The European Parliament Committee on the Environment, Public Health and Food Safety Committee has called for more EU self-sufficiency and better-coordinated strategies to tackle medicines shortages. The report asks the European Commission to use the upcoming pharmaceutical strategy to address the issue of availability, accessibility and affordability of safe medicines in Europe. See the press release here.

July 13, 2020

• The European Commission has published an updated version of its Q&A guidance on ‘conformity assessment procedures for protective equipment’. The guidance covers both PPE and medical devices, in particular in regard to the use of the Commission Recommendation (EU) 2020/403.
• The European Parliament has adopted a new Regulation that is intended to allow COVID-19 vaccines and treatments to be developed more quickly. The Regulation temporarily derogates from certain provisions of the genetically modified organism (GMO) Directive for clinical trials for COVID-19 vaccines and treatments that contain or consist of GMOs. The derogation should apply only to operations necessary to conduct the clinical trial phase and for compassionate or emergency use in the context of COVID-19. See the press release here.
• The European Commission has proposed a Regulation on the conduct of clinical trials and supply of medicinal products for human use containing or consisting of genetically modified organisms (GMOs) intended to treat or prevent COVID-19. The proposed Regulation has the effect of temporarily dispensing with the requirement of a prior environmental risk assessment and/or consent relating to packaging and labelling, transport, destruction, disposal, distribution, supply, administration or use of medicinal products containing or consisting of GMOs in clinical trials.

July 9, 2020

• The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a report summarising its second workshop on the development of COVID-19 vaccines. The report highlights key considerations and data requirements for the design and conduct of Phase 3 clinical trials.
• The EMA has provided a template and dedicated email address for a notification of a COVID-19 exceptional change management process (ECMP), as foreseen in the Q&A on regulatory expectations for medicinal products for human use during the COVID-19 pandemic. See the updated guidance here.

July 6, 2020

• The CHMP’s assessment report and the European Public Assessment Report (EPAR) for Veklury (remdesivir) for the treatment of COVID-19 have become available.
• The European Commission and the European Investment Bank (EIB) have provided CureVac (the German company developing a vaccine for COVID-19) with €75 million financing for vaccine development and expansion of manufacturing. See the press release here.

July 3, 2020

• The European Commission has granted a conditional marketing authorisation for remdesivir for the treatment of COVID-19 in adults and adolescents from 12 years of age with pneumonia who require supplemental oxygen. This follows the recommendation of the CHMP on 25 June 2020 and allows the medicine to be marketed in the EU. The invented name for the medicine is Veklury. See the EMA page on treatments and vaccines for COVID-19 here.
• The EMA has announced that it has been in contact with the developers of (i) 144 potential COVID-19 treatments; and (ii) 35 potential COVID-19 vaccines. See the EMA page on treatments and vaccines for COVID-19 here.

July 2, 2020

• The European Commission has issued guidance on the availability and capacity of notified bodies to carry out conformity assessments for COVID-19 related medical devices and in vitro diagnostic medical devices.
• The European Commission has issued guidance on the regulatory requirements for medical face masks, in regard to options for supporting production and / or the placing on the market of medical face masks in the context of the COVID-19 pandemic.

July 1, 2020

• The EMA has endorsed a joint statement on clinical trials from the International Coalition of Medicines Regulatory Authorities (ICMRA) which outlines the characteristics of COVID-19 trials most likely to generate conclusive evidence, and encourages adequate patient enrolment and public reporting of results. See the press release here.
• The EMA, the European Commission and the Heads of Medicines Agencies have updated their Q&A document on regulatory expectations for medicinal products for human use during the COVID-19 pandemic to cover pharmacovigilance inspections, system audits and the management of corrective and preventive actions (CAPAs).
• The EMA, the European Commission and the Heads of Medicines Agencies have updated their Q&A document on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic to cover pharmacovigilance inspections.

June 30, 2020

• The EMA and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have signed an agreement that allows them to share confidential information on medicines intended for the treatment, diagnosis, or prevention of COVID-19. See the press release here.

June 29, 2020

• The EMA has revised its guidance on the implications of COVID-19 on methodological aspects of ongoing clinical trials following a four-week public consultation. See the updated guidance here.

June 27, 2020

• The ‘Global Goal: Unite for our Future’ pledging summit organised by the European Commission and Global Citizen has mobilised €6.15 billion in additional funding to help develop and ensure equitable access to coronavirus vaccines, tests and treatments. This brings total pledges under the Coronavirus Global Response pledging marathon, launched by the European Commission President on 4 May 2020, to €15.9 billion. See the press release here.

June 25, 2020

• The EMA’s Human Medicines Committee (CHMP) has recommended for approval a conditional marketing authorisation for Veklury (remdesivir). This is the first treatment against COVID-19 to be recommended for authorisation in the EU. It is used to treat individuals over the age of 12 who experience pneumonia after contracting COVID-19. See the press release here.

June 24, 2020

• The EMA and the United States Food and Drug Administration (FDA) have jointly chaired the second regulatory workshop on the development of COVID-19 vaccines under the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants discussed certain methodological aspects and data requirements for the design and conduct of phase 3 clinical trials. See the press release here.
• The EMA has announced a new project to facilitate real-world monitoring of COVID-19 treatments and vaccines. The Agency has contracted an institution specialising in observational research to build a framework for the conduct of multicentre cohort studies on the use of medicines in COVID-19 patients. See the update here.

June 22, 2020

• The European Commission, EMA and FDA have agreed new priorities to strengthen their collaboration on medicines following their 2020 bilateral regulatory dialogue meeting on 18 and 19 June 2020. Key areas discussed include: (i) COVID-19 vaccines, (ii) individualised / bespoke therapies, (iii) real world evidence, (iv) the Mutual Recognition Agreement (MRA) of GMP inspections, and (v) orphan and paediatric medicines. See the press release here.

June 18, 2020

• The Commission has announced that countries within the EU can now apply for additional funding through the Emergency Support Instrument to transport essential medical goods, medical teams and patients affected by coronavirus. See the press release here.
• The Commission has announced that the supercomputer consortium Exscalate4CoV, funded by the EU through Horizon 2020, has discovered that an already registered generic drug used to treat osteoporosis, Raloxifene, could be an effective treatment for COVID-19 patients with mild or asymptomatic infection. See the press release here.

June 17, 2020

• The Commission has announced a European strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19. See the press release here.

June 16, 2020

• The EMA has updated its Treatments and vaccines for COVID-19 page to announce that it has been in contact with the developers of 132 potential COVID-19 treatments, and 34 potential COVID-19 vaccines.
• The Commission has launched an online public consultation on the Pharmaceutical Strategy for Europe. The Strategy will be informed by the challenges amplified by the COVID-19 pandemic. See the press release here.
• Member States, with the support of the Commission, have agreed on a set of technical specifications to ensure a safe exchange of information between national contact tracing apps based on a decentralised architecture. This means that national apps will work when users travel to another EU country which also follows the decentralised approach, marking an important step towards the interoperability of mobile apps for tracing COVID-19 infections as Member States begin to lift travel restrictions across borders. See the press release here.

June 15, 2020

• The EMA has published a regulatory update following the latest meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA). ICMRA members reiterated that the research community should pool resources into large, well-designed, randomised clinical trials to determine which investigational or repurposed medicines would be safe and effective for the treatment or prevention of COVID-19. In addition, participants discussed the use of COVID-19 clinical trial master protocols around the world to accelerate the development and approval of potential treatments and vaccines against COVID-19.
• The EMA has introduced a fee for its rolling review procedure, which is deductible from the fee the EMA would charge for a marketing authorisation application when the company submits the full dossier following the rolling review. Micro, small and medium-sized enterprises (SMEs) are eligible for a 90% fee reduction for the rolling review. See the revised implementing rules to the Fee Regulation here.

June 11, 2020

• The European Investment Bank (EIB) is to provide BioNTech with up to €100 million in debt financing for COVID-19 vaccine development and manufacturing. See the press release here.

June 10, 2020

• The European Commission has provided the ‘Expert Panel on effective ways of investing in health’ with a mandate to consider a new framework for the organisation of health and social care following the COVID-19 pandemic. The Panel has been asked to provide its analysis and recommendations by November 2020.
• The EMA has published guidance on remote good clinical practice (GCP) inspections during the COVID-19 pandemic, described as the first in a series of guidance documents on remote inspections for the verification of compliance with EU and international standards during the pandemic.
• The EMA has extended its medical literature monitoring service to cover authorised active substances that could help to treat COVID-19.
• The EMA has announced that the latest data supports the continued use of ACE-inhibitors and ARB medicines during the COVID-19 pandemic. See the press release here.

June 8, 2020

• The European Commission has announced that it has awarded nearly €166 million, via the European Innovation Council (EIC) Accelerator Pilot, to 36 companies set to combat the coronavirus pandemic. In addition, over €148 million will be granted to another 36 companies set to contribute to the recovery plan for Europe, bringing the total investment from Horizon 2020, the EU's research and innovation programme, to €314 million in this round. See the press release here.
• The EMA has published an update on EU actions to support the availability of medicines during the COVID-19 pandemic, following the latest meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events on 3 June 2020.
• The CHMP has started to formally evaluate remdesivir for a conditional marketing authorisation. Further, the EMA has published its decision on the paediatric investigation plan (PIP) for remdesivir. See the press release here.
• The EMA has published a visual guide on its fast-track procedures for COVID-19 treatments and vaccines.

June 5, 2020

• The European Commission has approved a €5 billion French “umbrella” scheme to support research and development, testing and upscaling infrastructures and production of COVID-19-relevant products. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March 2020, as amended on 3 April and 8 May 2020. See the press release here.

June 4, 2020

• As part of the European Commission’s Coronavirus Global Response, the Commission has pledged €300 million to Gavi, the Vaccine Alliance, for the period 2021–2025. See the press release here.
• On 2 June 2020 the EMA updated patients’ and healthcare professionals’ organisations about its COVID-19-related activities at a virtual meeting with the Patients’ and Consumers’ Working Party and the Healthcare Professionals’ Working Party. A recording of the meeting is available here. See the press release here.
• The Medical Device Coordination Group (MDCG) has issued guidance in respect of Commission Implementing Regulation (EU) 2020/666, which permits member states to derogate from the normal procedures required for the re-designation and surveillance of notified bodies, and to allow such re-designation to occur until 25 May 2021. The guidance also notes that any decision of a competent authority to re-designate a notified body should be notified to the Commission and the other member states via the New Approach Notified and Designated Organisations information system.
• The EMA has published a revised version of its guidance on regulatory flexibilities for MAHs during the COVID-19 pandemic. The most recent updates explain additional flexibilities being afforded in relation to Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) as well as the inspection of plasma collection centres.
• The EMA has announced that it has broadened the mandate of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) in the context of the COVID-19 pandemic. Under the terms of the broadened mandate, the ENCePP will take a leading role in the monitoring and surveillance of potential therapeutics and vaccines following their authorisation.

June 2, 2020

• The EMA and the United States Food and Drug Administration (FDA) have published guidance on joint procedural assistance for medicine developers planning to submit a paediatric investigation plan (PIP) to the EMA and an initial pediatric study plan (iPSP) to the FDA for a COVID-19 vaccine or treatment. The aim of the joint document is to make it easier for developers to submit paediatric development plans simultaneously to the regulators.

May 29, 2020

• The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a report summarising its global regulatory workshop on COVID-19 observational studies and the use of real-world data. The report provides an overview of global regulators’ priority areas for cooperation in the areas of pregnancy research, building international clinical cohorts, and preparing for vaccine safety and effectiveness monitoring.
• The EMA has reminded healthcare professionals to closely monitor patients with COVID-19 who are receiving chloroquine or hydroxychloroquine. Several observational studies in COVID-19 have reported that chloroquine and hydroxychloroquine are associated with an increased risk of heart problems, including cardiac arrhythmias and cardiac arrest. See the press release here.

May 28, 2020

• On 25 May 2020 the European Commission issued guidance entitled ‘How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context.’

May 27, 2020

• The EMA has announced that it has been in contact with the developers of around 125 potential COVID-19 treatments and 33 potential COVID-19 vaccines.
• The EMA has commissioned independent research from Utrecht University into data sources and methods that can be used to monitor the safety, effectiveness and coverage of COVID-19 vaccines in clinical practice once they are authorized in the EU. This research will be conducted under the ACCESS (vACcine COVID-19 monitoring readinESS) project. See the press release here.

May 26, 2020

• The EMA has called for collaboration between EU researchers on high-quality observational studies of COVID-19 treatments and vaccines. A new COVID-19 response group set up by the European Network of Centres for Pharmacoepidemiology and Pharmacoviligance (ENCePP) is in place to facilitate this collaboration. See the press release here.

May 25, 2020

• The European Commission has published the draft agenda for the ‘COVID-19 meeting of the Competent Authorities for Blood and Blood Components’ on June 3, 2020.

May 20, 2020

• The EMA and Health Canada co-hosted the fourth global regulatory workshop under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA). Participants identified priority areas for cooperation on observational research during COVID-19: pregnancy research, medicines used in clinical practice, and monitoring vaccine safety and effectiveness. See the press release here.
• The European Commission has published the European Semester 2020 Spring Package, in which the Commission has proposed country-specific recommendations (CSRs) that require each Member State to take steps to strengthen the resilience of its national health system. It is the first time, in the wake of the ongoing COVID-19 crisis, that the Commission has proposed health recommendations to all Member States. See the press release here.
• The European Commission has mobilised a further €122 million from its research and innovation programme, Horizon 2020, for research into COVID-19. The deadline for submission is 11 June 2020. See the press release here.

May 18, 2020

• The EMA has published an update following the latest meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA). The meeting underlined the need and commitment by global regulators to cooperate and align their approaches to clinical trial management, medicine supply issues and pharmacovigilance in light of COVID-19.
• The EMA’s Executive Director, Guido Rasi, attended the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) to respond to questions on EMA’s response to COVID-19. A recording of the session is available here.

May 15, 2020

• In an article published in Clinical Pharmacology & Therapeutics, the EMA has set out concrete actions that stakeholders involved with COVID-19 clinical trials should take to generate the type of conclusive evidence needed to enable rapid development and approval of potential treatments and vaccines against COVID-19. This follows concerns about the growing number of COVID-19 stand-alone clinical trials, with a small number of participants and observational studies, which might not generate the data required for regulatory decision-making. See the EMA press release here.
• The EMA has published an update on EU actions to support the availability of medicines during the COVID-19 pandemic which summarises the latest meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.

May 14, 2020

• The EMA held a virtual press briefing explaining its efforts to expedite the development and approval of COVID-19 treatments and vaccines, its role in ensuring the continued availability of crucial medicines in the EU during the pandemic, and its publication of reliable information for patients and healthcare professionals. A recording of the briefing is available here.

May 13, 2020

• Member States, supported by the European Commission and the eHealth Network, have adopted interoperability guidelines for approved contact tracing mobile applications in the EU. A key principle of the guidelines is that users should be able to rely on a single app wherever they are in the EU at a certain moment. The idea is to prevent the possibility for the identification of app users, whether infected, exposed or otherwise, unless the individuals in question have voluntarily provided that information or want to contact the health authority.
• The EMA’s Executive Director briefed the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) on EMA’s response to COVID-19. A recording of the session is available here.

May 12, 2020

• The European Commission has announced that 8 large-sale research projects aimed at developing treatments and diagnostics for COVID-19 have been selected in the fast-track call for proposals launched in March by the Innovative Medicines Initiative (IMI), a public-private partnership. €117 million will be granted to fund the proposals, including €72 million from Horizon 2020, the EU’s research and innovation programme. See the press release here.
• The European Commission has approved a Maltese aid scheme of €11.5 million to support investment in products relevant to the COVID-19 outbreak, including vaccines, ventilators and PPE. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March 2020, as amended on 3 April and 8 May 2020. See the press release here.

May 11, 2020

• The EMA’s human medicines committee (CHMP) has recommended expanding the compassionate use of the investigational medicine remdesivir. In addition to patients undergoing invasive mechanical ventilation, the compassionate use recommendations now cover the treatment of hospitalised patients requiring supplemental oxygen, non-invasive ventilation, high-flow oxygen devices or extracorporeal membrane oxygenation (ECMO). This recommendation is based on data from the EMA’s rolling review of remdesivir announced last month.

May 8, 2020

• Latest meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events. Participants discussed potential improvements to the current way in which the supply of medicines used in intensive care units (ICUs) matches the demand at national level. The heads of the national competent authorities agreed to explore how national data models to forecast the demand can be shared within the EU medicines regulatory network. The group also received an update from the EMA on the progress of the i-SPOC fast-track monitoring system for crucial medicines used in the context of COVID-19. See the press release here.

May 7, 2020

• The EMA has updated the eSubmission Gateway user interface to allow applicants to flag submissions related to COVID-19. The aim is to help the EMA rapidly identify and prioritise COVID-19-related submissions.

May 5, 2020

• Latest meeting of the International Coalition of Medicines Regulatory Authorities (ICMRA), organised by the EMA. Participants stressed the need for alignment on pre- and post-authorisation regulatory requirements to facilitate the rapid development, evaluation and availability of medicines for the treatment and prevention of coronavirus disease. See the press release here.

May 4, 2020

• The EMA, the European Commission and the national competent authorities have published a Q&A document on regulatory expectations for medicinal products for veterinary use during the COVID-19 pandemic. This guidance sets out the adaptions to the regulatory framework, covering marketing authorisation procedures, pharmacovigilance and good manufacturing practice (GMP) certificates, and inspections for veterinary medicines. See the press release here.
• The EMA has updated its guidance for marketing authorisation holders on how to submit COVID-19-related individual case safety reports (ICSR) to EudraVigilance. The update follows the implementation of version 23.0 of the Medical Dictionary for Regulatory Activities (MedDRA), containing additional COVID-19-related terms in EudraVigilance.
• The EMA has published guidance for developers on the rapid review procedures it has put in place to speed up development and approval of COVID-19 treatments and vaccines. See the press release here.

April 30, 2020

• The EMA has published its latest update on EU actions to support the availability of medicines during COVID-19 pandemic. Among other developments, the EU authorities are finalising a Q&A document for marketing authorisation holders (MAHs) of veterinary medicines as well as an update of the Q&A document for MAHs of human medicines. See the press release here.
• The EMA’s human medicines committee (CHMP) has started a “rolling review” of data on the use of the investigational antiviral medicine remdesivir for the treatment of COVID-19. A rolling review is one of the regulatory tools available to the EMA to speed up the assessment of a promising investigational medicine during a public health emergency, such as the ongoing pandemic. The start of the review does not imply that the benefits of remdesivir outweigh its risks. See the press release here.
• The EMA has endorsed a joint COVID-19 statement published by the International Coalition of Medicines Regulatory Authorities (ICMRA) committing to a strengthening of global collaboration in the fight against coronavirus disease. The statement asserts that regulator collaboration “is crucial to increase the efficiency of regulatory processes and decision-making that will facilitate rapid development, approval and global roll-out of safe and efficacious medicines against COVID-19”. See the press release here.

April 29, 2020

• The European Commission has published the comfort letter it issued to Medicines for Europe on 8 April 2020 in relation to a voluntary cooperation project to address the risk of shortages of critical hospital medicines for the treatment of coronavirus patients.
• The European Commission has approved a German “umbrella” scheme to support research, development, testing and production of coronavirus relevant products. The scheme was approved under the State aid Temporary Framework adopted by the Commission on 19 March 2020, as amended on 3 April 2020. See the press release here.

April 28, 2020

• The European Commission has issued updated guidance on the management of clinical trials during the COVID-19 pandemic. See the press release here.
• The CMDh has issued guidance for facilitating the handling of processes during the COVID-19 pandemic. The guidance states that timelines for the assessment of marketing authorisation application or post-authorisation procedures may be delayed in certain circumstances for products which are not critical or directly linked to the COVID-19 outbreak. Further, EU regulators have agreed to allow a “freezing” and “rolling” back of the procedural timetable for certain regulatory procedures due to unexpected and COVID-19 related capacity issues.

April 27, 2020

• The European Commission has approved a €4 million Belgian scheme to support coronavirus-related research and development (R&D) projects in the Brussels-Capital region. The scheme was approved under the State aid Temporary Framework adopted by the European Commission on 19 March 2020, as amended on 3 April 2020. See the press release here.

April 24, 2020

• The EMA and the national competent authorities are reminding patients with confirmed or suspected COVID-19 to report suspected side effects that they experience with any of the medicines they are taking. This includes medicines to treat COVID-19 and to manage long-term, pre-existing conditions, as well as medicines that patients might be using off-label to treat COVID-19. See the press release here.
• The EMA has published a summary of the latest meeting of the EU Executive Steering Group on Shortages of Medicines Caused by Major Events.

April 23, 2020

• The European Parliament and European Council have adopted the European Commission’s proposal to postpone the date of application of the Medical Devices Regulation by one year. See the press release here.

April 21, 2020

• The EMA, together with the pharmaceutical industry and EU Member States, has launched i-SPOC, its enhanced fast-track monitoring system designed to help prevent and mitigate supply issues with crucial medicines used for treating patients with COVID-19. See the press release here.

April 20, 2020

• The European Commission has launched a European COVID-19 Data Platform to ensure the rapid collection and sharing of available research data. The platform is part of the ERAvsCorona Action Plan. See the press release here.

April 16, 2020

• Fourth ICMRA meeting of global regulators. Participants shared various agile and accelerated regulatory measures implemented in different countries to mitigate the impact of the COVID-19 outbreak. They agreed that regulatory rules should be applied with greater flexibility during the pandemic to facilitate development of potential COVID-19 treatments and secure continued supply of medicines.

April 10, 2020

• The European Commission, EMA and the European medicines regulatory network have developed a question-and-answer document to provide guidance to stakeholders on adaptations to the regulatory framework to address challenges arising from the COVID-19 pandemic, with a particular focus on crucial medicines for use in COVID-19 patients.
• The EMA is currently setting up the i-SPOC (industry single point of contact) system through which pharmaceutical companies can report directly to the Agency any issues related to the availability of crucial medicines being used in the context of COVID-19. See the press release here.

April 9, 2020

• The EMA has published the composition and objectives of its COVID-19 EMA pandemic Task Force (COVID-ETF), which assists Member States and the European Commission in dealing with development, authorisation and safety monitoring of therapeutics and vaccines intended for treatment or prevention of COVID-19.

April 8, 2020

• The European Commission has published a Temporary Framework Communication to provide antitrust guidance to companies cooperating in response to urgent situations related to the current coronavirus outbreak, as well as a comfort letter to Medicines for Europe concerning a specific cooperation project aimed at avoiding situations of shortages of critical hospital medicines. See the press release here.
• The European Commission has published guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak.

April 6, 2020

• At the third ICMRA meeting co-chaired by the EMA and Health Canada, participants discussed how data generated during clinical practice in the treatment of COVID-19 could complement evidence from clinical trials of potential COVID-19 treatments and vaccines. See the press release here.

April 3, 2020

• The CHMP gave recommendations on how the investigational antiviral medicine remdesivir should be used for treating COVID-19 in compassionate use programmes in the EU.
• The European Commission has adopted an amendment extending the State Aid Temporary Framework to enable Member States to accelerate the research, testing and production of COVID-19 relevant products. See the press release here.

April 2, 2020

• Second ICMRA meeting co-chaired by the EMA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Participants discussed the available knowledge on possible treatments (drugs and biologics) for COVID-19. See the press release here.

April 1, 2020

• EMA alert: is very important that patients and healthcare professionals only use chloroquine and hydroxychloroquine for their authorised uses or as part of clinical trials or national emergency use programmes for the treatment of COVID-19.

March 30, 2020

• The EMA is to issue electronically signed and authenticated certificates for medicines in place of printed certificates during the COVID-19 pandemic. See the press release here.
• The European Commission has made available guidance to assist manufacturers in ramping up production of masks and other PPE, leave-on hand cleaners and hand disinfectants and 3D printing.

March 27, 2020

• The EMA and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have encouraged all researchers to register their pharmacoepidemiological studies related to the COVID-19 pandemic in the EU PAS Register.
• MedTech Europe has published guidance which aims to support medtech companies’ legal and/or compliance teams when considering emergency processes to fast-track requests related to the COVID-19 crisis.
• The EMA, the European Commission and the Heads of Medicines Agencies updated their guidance on the management of clinical trials during the COVID-19 pandemic to cover safety reporting, the distribution of in-vitro diagnostics, medical devices and auditing. 

March 25, 2020 

• The EMA has issued draft guidance entitled ‘Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials’. The guidance is under a four-week public consultation until 25 April 2020.
• The European Commission announced that it is working on a proposal to postpone the application date of the MDR for one year ongoing. The goal is to submit this proposal in early April so that the European Parliament and Council can adopt it by the end of May.

March 24, 2020

• The European Commission has announced the creation of Exscalate4CoV, its second-largest consortium. The consortium will work to resolve the 3D structures of essential coronavirus proteins. This data will be used to generate computer models of likely future mutations of the virus, and as the basis for in silico screening of compound libraries.
• The European Commission announced that it has selected 17 COVID-19 research projects to receive €47.5m funding through Horizon 2020.

March 24, 2020 

• The Innovative Medicines Initiative (IMI) has also announced a call for COVID-19 research proposals (deadline 31 March 2020). The combined funding for this project could total up to €90 million.

March 20, 2020

• The European Commission has published guidance on the management of clinical trials during the COVID-19 pandemic.
• The EMA will give priority to any new clinical trial applications for the treatment or prevention of COVID-19 infection, and / or substantial amendment applications to existing clinical trials necessary as a result of COVID-19. See the guidance here.

March 19, 2020

• The CHMP has published a statement urging the EU research community to prioritise large randomised controlled studies because they are most likely to generate the conclusive evidence needed to enable rapid development and approval of potential treatments of COVID-19.

March 18, 2020

• The International Coalition of Medicines Regulatory Authorities (ICMRA) has published a summary report of the first global regulatory workshop on COVID-19 vaccine development, which was co-chaired by the EMA and the FDA.
• The EMA, European Commission and national competent authorities have organised the first meeting of the EU Executive Steering Group on shortages of medicines caused by major events. Article here.

March 13, 2020

• The European Commission has issued Commission Recommendation (EU) 2020/403, which provides that in order to address the shortage of medical devices and PPE, certain devices/equipment may be marketed before having been subject to the fundamental conformity assessment procedure.

April 3, 2020

• The NMPA issued a Notice emphasizing export controls on Chinese manufactured drugs during the current public health emergency. The Notice made it clear that local medical products’ administrations shall carry out strict controls on issuance and management of pharmaceutical export certificates such as certification documents for export of APIs to the EU, export certificates for pharmaceuticals, anabolic agents and peptide hormone. The export certificate will be cancelled if the manufacturer fails to comply with applicable requirements or the products are manufactured not in compliance with China GMPs.

March 31, 2020

• Three departments including the Ministry of Commerce (MOFCOM), the General Administration of Customs (GAC), and the NMPA jointly published the Announcement on the Orderly Export of Medical Supplies (No.5 2020) (“Announcement”). Under the Announcement, beginning April 1, 2020, to be exported, certain medical devices (novel coronavirus testing agents, medical masks, medical gowns, ventilator, infrared thermometer) need to have China’s medical device registration certificates and to meet the quality standards of the importing countries.

March 30, 2020

• Since the outbreak of COVID-19, the National Medical Products Administration (NMPA) has launched an emergency approval procedure for medical devices including COVID-19 testing reagents, medical masks, and medical protective clothing. As of March 30, 2020, the NMPA approved 23 COVID-19 detection reagents under the emergency procedure, including 15 nucleic acid detection reagents and eight antibody detection reagents.

January 17, 2021

• The DHSC has announced that the use of the latest artificial intelligence will provide faster treatment, improved outcomes and shorter hospital stays for COVID-19 patients. Access to an artificial intelligence instrument, the National COVID–19 Chest Imaging Database (NCCID), has been extended to hospitals and universities across the UK to help speed-up diagnosis of COVID-19, leading to a quick treatment plan and greater understanding of whether the patient may end up in a critical condition. Additionally, NHSX (a unit tasked with driving the digital transformation of care in the NHS) has brought together over 40,000 CT scans, MRIs and X-rays from more than 10,000 patients across the UK during the course of the COVID-19 pandemic. See the press release here.

January 10, 2021

• The DHSC has announced that the community testing offer is to be expanded across all local authorities in England to test people without COVID-19 symptoms. Local authorities will be encouraged to target testing to people who cannot work from home during lockdown. See the press release here.
• The DHSC has announced that the UK government has ordered two million of the first British-manufactured tests to be validated by Public Health England, for use in asymptomatic testing. Derby-based company SureScreen Diagnostics is to provide two million of the lateral flow tests, which provide results in under 30 minutes, by Friday, January 15, with the potential to provide millions more in the coming months. See the press release here.

January 8, 2021

• The MHRA has announced that it has approved a third COVID-19 vaccine for use in the UK, developed by Moderna. See the press release here.

January 7, 2021

• As part of the Access Consortium, the MHRA is collaborating with the medicine regulators from Australia, Canada, Singapore, Switzerland to advance the regulatory science needed to support the rapid development of diagnostic tests, as well as vaccines and treatments against COVID-19. The Access Consortium members have discussed the regulatory evidence requirements for COVID-19 vaccine approvals and considerations for post-market pharmacovigilance. See the Policy Paper here.

December 30, 2020

• The MHRA has announced that it has given regulatory approval to the COVID-19 vaccine developed by Oxford University/AstraZeneca. The data has been reviewed in stages, as it became available, under the rolling review process. See the press release here. Also, see here for information for healthcare professionals and the public about the COVID-19 Vaccine AstraZeneca.

December 23, 2020

• The MHRA has issued an exceptional use authorisation to the Department of Health and Social care to allow the use of the NHS Test and Trace COVID-19 Self-Test kit, to be used by members of the public, to detect infection in asymptomatic individuals; this rapid test can give a result in 30 minutes. See the press release here.

December 22, 2020

• The MHRA has announced that the National Institute for Biological Standards and Control (NIBSC) will carry out independent batch release testing in the UK for any potential COVID-19 vaccines. See the press release here.

December 19, 2020

• Temporary changes to the Human Medicines Regulations 2012 have been introduced by The Human Medicines (Coronavirus) (Further Amendments) Regulations 2020 to deal with five legal issues that have emerged in the early stages of the mass vaccination campaign against COVID-19 and to correct errors made by the Human Medicines (Amendments etc.) (EU Exit) Regulations that arise out of a failure to take account of the Human Medicines (Coronavirus and Influenza) (Amendment) Regulations 2020 to restore the effect of some of the changes made by the C&I Regulations in England, Northern Ireland, Scotland, Wales.

December 17, 2020

• The Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020 have been introduced to make COVID-19 testing exempt as a regulated activity under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This removes the Care Quality Commission (CQC) registration requirements for COVID-19 test providers who may have been in the scope of CQC registration under the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.
• The Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020 have been introduced. These Regulations require all private coronavirus test providers to become accredited by the United Kingdom Accreditation Service (UKAS).

December 7, 2020

• The Department of Health and Social Care (DHSC) has announced a new means of accreditation for private COVID-19 tests. The new proposals will see commercial testing accredited solely through UKAS, making the accreditation of private COVID-19 tests faster and more efficient. Commercial providers of COVID-19 testing are being urged to sign up to new DHSC webinars to learn more about this accreditation. See the press release here.

November 16, 2020

• The Department of Health and Social Care has announced that two new megalabs to open in 2021 to transform the UK’s diagnostic facilities. When operating at full capacity, the two new labs will add 600,000 to the UK’s daily testing capacity for COVID-19, meaning faster turnaround for test results; not only will the 2 labs be used to process COVID-19 tests, but the significant boost in diagnostic capabilities will be used for critical illness including cancer, cardiovascular and metabolic diseases. The labs will form ‘a key part of the UK’s national infrastructure to respond to future epidemics’. See the press release here.
• The Department of Health and Social Care has announced a £12.2m funding boost for genomic surveillance to help stop the transmission of coronavirus (COVID-19) and investigate how coronavirus spreads and evolves. The funding will be used by the COVID-19 Genomics UK Consortium will use the funding to expand whole genome sequencing of the SARS-CoV-2 virus. This research will also assist in developing potential vaccines in the future because the research is essential for monitoring the evolution of COVID-19 for mutations which may impact the efficacy of vaccines. See the press release here.

November 11, 2020

• The MHRA has published guidance to assist those involved in running clinical trials of medicines to minimise disruption as a result of the continuing COVID-19 pandemic and to support appropriate incorporation of the available flexibilities into normal practice for the benefit of trial participants. See the guidance here.

November 9, 2020

• The MHRA has updated its guidance on clinical trials applications for COVID-19. It has added a new section on COVID-19 trial related activity and a new email address to contact the clinical trials unit on. See the update here.

November 8, 2020

• The UK government has agreed a series of measures with representatives of Facebook, Twitter and Google to help combat the spread of misinformation about COVID-19 vaccines. Two fundamental principles were agreed: (i) no user company should directly profit from the spread of misinformation or disinformation about vaccines; and, (ii) social media companies should work with public health bodies to promote factual and reliable messaging about vaccines. See the press release here.

October 30, 2020

• The largest COVID-19 antibody testing programme has published its findings on antibody response over time. Over 365,000 randomly selected adults tested themselves at home using a finger-prick test between June 20 and September 28 to check if they had antibodies against COVID-19. The findings from Imperial College London and Ipsos MORI shows the number of people with antibodies fell by 26% over 3 months (from 6% of the population having antibodies to 4.4% of the population). See the press release here.

October 27, 2020

• The MHRA has started the rolling review process of mRNA-1273, Moderna’s vaccine candidate against COVID-19. See the press release here.
• The largest COVID-19 antibody testing programme has published its findings on antibody response over time. Over 365,000 randomly selected adults tested themselves at home using a finger-prick test between 20 June and 28 September to check if they had antibodies against COVID-19. The findings from Imperial College London and Ipsos MORI shows the number of people with antibodies fell by 26.% over 3 months (from 6% of the population having antibodies to 4.4% of the population). See the press release here.

October 26, 2020

• The MHRA has published guidance on notifications of COVID-19 and influenza point of care testing (POCT) results and the legal duties for providers of POCT. The Health Protection (Notification) Regulations 2010 are being amended to require that, in addition to positive cases, laboratories must now report indeterminate, negative and void results from POCT to identify the causative agents for COVID-19 and influenza. See the guidance here.

October 23, 2020

• MHRA has signed a £1.5m contract with a software company, Genpact UK, to develop an AI tool to process the expected high volume of COVID-19 vaccine Adverse Drug Reaction.

October 22, 2020

• The UK Department of Health and Social Care and the MHRA have given Flublok authorization for temporary supply as part of the UK’s 2020/21 seasonal flu programme to help meet high demand for vaccination amid the COVID-19 pandemic. See the press release here.

October 21, 2020

• The Department of Health and Social Care (DHSC) has launched a new portal to report potential medicine shortages aiming to improve the management of supply issues which have been exacerbated by the COVID-19 pandemic and to allow the tracking of any actions taken to mitigate them. An explanation for marketing authorization holders on how to use the new discontinuations and shortages (DaSH) portal has been published in the DHSC’s updated guidance on reporting potential supply issues to the DHSC. See the guidance here.

October 20, 2020

• The Department for Business, Energy & Industrial Strategy (BEIS) and the Department of Health and Social Care (DHSC) have announced that the UK government will invest £33.6 million to explore and establish Human Challenge studies to accelerate the development of a COVID-19 vaccine, in partnership with Imperial College London, hVIVO and the Royal Free London NHS Foundation Trust. See the press release here.  
• The MHRA has announced that the National Institute for Biological Standards and Control (NIBSC) will play a key role in evaluating vaccines that have been developed for COVID-19. The NIBSC is one of seven partner laboratories that have been selected by CEPI (the Coalition for Epidemic Preparedness Innovations) to form a centralised laboratory to standardise the measurement of immune responses generated by multiple COVID-19 vaccine candidates. Additionally, the NIBSC  has received funding from CEPI to develop an International Standard for COVID-19 antibody. See the press release here.

October 16, 2020

• Following a public consultation on changes to the Human Medicines Regulations 2012 to support the rollout of COVID-19 vaccines, the government has proceeded with the changes proposed with new legislation introduced on 16 October 2020 but the Department of Health and Social Care has modified the proposals in three key ways. See the Consultation outcome here.

October 15, 2020

• The MHRA has updated its guidance on how COVID-19 tests and testing kits work to add a ‘Target Product Profile’ for Laboratory-Based SARS-CoV-2 Viral Detection Tests.

October 13, 2020

• The MHRA has issued advice to patients and healthcare professionals on the monitoring of patients taking blood thinning tablets (also known as anticoagulants) during the COVID-19 pandemic. See the guidance here.

October 8, 2020

• The Health and Social Care and Science and Technology Select Committees have launched an inquiry into lessons learnt from the response to the COVID-19 pandemic so far. The issues that the two Select Committees will focus on include testing and contact tracing, the development of treatments and vaccines, and government public health communications. See the press release here.

October 6, 2020

• The UK Department of Health and Social Care (DHSC) has signed a deal with the UK Rapid Test Consortium (UK-RTC) for 1 million antibody tests. See the press release here.

October 5, 2020

• The MHRA has updated its guidance on clinical trials applications for COVID-19. It has added new information about how to arrange an informal regulatory advice meeting, an optional pre-assessment service for COVID-19 clinical trials and the average time for approving COVID-19 initial applications. See the update here.

September 29, 2020

• The UK Department of Health and Social Care (DHSC) has signed a new £150 million contract with Novacyt for COVID-19 testing kits and PCR machines, with the potential for a further £100m of supply. See the press release here.
• The NHS Confederation has published two reports on resetting the NHS and addressing health equalities that the COVID-19 pandemic has highlighted. See the press release here.

September 28, 2020

• The UK Government has published a new strategy for preparing for a second wave of COVID-19 covering supply and logistics for distribution of PPE.

September 24, 2020

• The Department of Health and Social Care (DHSC) launches its NHS COVID-19 app to help control COVID-19 transmission alongside national and local contact tracing. See the press release here.

September 18, 2020

• England has introduced Regulations that make it a legal requirement for specified hospitality, leisure and community premises to collect customer and staff data for contact tracing purposes and to display an official QR code. This requirement has already been introduced in Scotland and Wales.

September 11, 2020

• The UK government has announced £270,000 funding to support research at St Andrews University testing different surfaces and coatings for their effectiveness in killing the COVID-19 virus.
• The National Institute for Health Research (NIHR) and UK Research and Innovation (UKRI) have awarded a total of £5.3 million funding to eight new research projects investigating how coronavirus spreads. These research projects will help inform policy decisions about COVID-19, including infection prevention strategies and containment measures.

September 3, 2020

• The UK government has announced that a new £500 million funding package will be invested in next generation testing technology and increased testing capacity. The funding will be directed towards quick result test trials and repeat population testing.

August 28, 2020

• The government has announced new measures to support the development of COVID-19 vaccines in the UK, including (i) reinforced safeguards to support the MHRA to grant temporary authorisation for the use of a new COVID-19 vaccine; (ii) expanding the trained workforce who can administer COVID-19 and cold and flu vaccines; and (iii) clarifying the scope of protection from civil liability of the additional workforce that could be allowed to administer vaccinations.
• The government is investing £8.4 million in COVID-19 immunology research projects across the UK. Three new UK-wide studies will receive funding from UK Research and Innovation (UKRI) and the National Institute for Health Research (NIHR) to understand immune responses to COVID-19. See the press release here.
• The MHRA has updated the list of medical devices given exceptional use authorisations during the COVID-19 pandemic with new additions and expired authorisations.

August 21, 2020

• The VMD has announced that it will resume on-site inspections of manufacturers, wholesalers, vet practices, feed business operators and SQP retailer premises on 24 August 2020. On-site inspections of the pharmacovigilance (PhV) systems of Marketing Authorisation Holders will re-start at a later date. In the meantime, the VMD will continue to inspect PhV systems remotely.<

August 18, 2020

• The UK government has announced the creation of a new National Institute for Health Protection (NIHP), which will bring together Public Health England (PHE), NHS Test and Trace, and the Joint Biosecurity Centre (JBC) under a single command structure. The responsibilities of the NIHP will include advancing the country’s response to the COVID-19 pandemic, including managing the UK’s COVID-19 testing programme.

August 11, 2020

• The MHRA has issued guidance for industry on the MHRA’s expectations for return to GxP on-site inspections. This follows suspension of the GxP inspection programme in March 2020 due to COVID-19 social distancing and travel restriction requirements. The inspectorate plans to resume an on-site UK risk-based GxP inspection programme starting in September, scaling up to a full programme from October 2020.

August 7, 2020

• The UK government has announced a new study into the long-term physical and mental health implications of COVID-19. The study has been awarded £8.4 million in funding through UK Research and Innovation (UKRI) and the National Institute for Health Research (NIHR). See the press release here.

August 4, 2020

• The MHRA has updated its guidance on regulatory flexibilities resulting from COVID-19 to identify areas of flexibility which differ from the EU. The MHRA has also identified some UK flexibilities which align with the EU but are not limited to treatments of COVID-19 products, i.e. they also cover the supply of other essential products that have been affected by the outbreak.

August 3, 2020

• The Veterinary Medicines Directorate (VMD) has published a statement on the new temporary enforcement policy under specific COVID-19 circumstances. The policy will be effective from 1 September 2020, when the current temporary relaxation of enforcement of certain provisions of the Veterinary Medicines Regulations (VMR) will cease.

August 3, 2020

• The Veterinary Medicines Directorate (VMD) has announced the phasing out of COVID-19 facilitations. This applies to the relaxation of enforcement of specific provisions of the Veterinary Medicines Regulations (VMR) in regard to: (i) SQPs prescribing and authorising supply of veterinary medicines remotely; (ii) temporary change of SQP retailer premises; (iii) temporary change of veterinary practice premises; and (iv) temporary changes to the retail supply of veterinary medicines. The VMD is also phasing out the temporary change to the standard guidance on manufacturers of extemporaneous preparations for use under the cascade (ManSA). The COVID-19 measures will continue to apply to 31 August 2020 and then will cease.

July 29, 2020

• The MHRA has announced the creation of two innovative synthetic datasets intended to support the development of medical technologies to fight COVID-19. The datasets have been generated to accurately mirror symptoms, diagnoses and treatments in genuine patients. For access to the data sets, applicants should contact the Clinical Practice Research Datalink (CPRD). See the press release here.

July 24, 2020

• The UK government has announced an additional £100 million in funding for the construction of a new manufacturing centre intended to accelerate the mass production of a successful COVID-19 vaccine.

July 23, 2020

• The MHRA is making preparations for a return to on-site Good Practice (GxP) inspections in September, with a plan to scale up to a full programme from October 2020. Until the full programme resumes, the agency will continue to utilise its COVID-19 procedures of remote assessment. There are still no plans for a return to on-site international inspections. See the MHRA Inspectorate Blog here.

July 14, 2020

• The MHRA has updated its guidance on regulatory flexibilities resulting from COVID-19 to add further information on audits of Notified Bodies and manufacturers in the 'Medical Devices' section. 

July 13, 2020

• The MHRA has updated its guidance on regulatory flexibilities resulting from COVID-19 to include information for manufacturers of human plasma-derived medicines during the COVID-19 outbreak.
• The MHRA has updated its list of medical devices given exceptional use authorisations during the COVID-19 pandemic.

July, 10 2020

• The MHRA has updated its guidance on how tests and testing kits for COVID-19 work to re-write the section ‘For patients, the public and professional users: a guide to COVID-19 tests and testing kits’ to make it clearer how the different types of tests work, and who can use them.

July 2, 2020

• Public Health England (PHE) has published its Vaccine Update for June 2020. The issue includes guidance on immunisation training during the COVID-19 pandemic. 

June 29, 2020

• The CMA and General Pharmaceutical Council have published a joint letter to pharmacy owners and superintendent pharmacists in regard to price increases for essential products during the COVID-19 pandemic.
• The MHRA has updated its guidance on the regulatory status of equipment being used to help prevent COVID-19 to include explanations in regard to the regulations for face coverings.

June 26, 2020

• The MHRA has approved the recruitment of further participants for a University of Oxford clinical trial investigating hydroxychloroquine in the prevention of COVID-19. The decision follows the MHRA’s instructions of 8 June 2020 to suspend recruitment of participants for clinical trials that used hydroxychloroquine to treat or prevent COVID-19. The University of Oxford submitted justifications and supporting information which was reviewed by the MHRA, with independent advice obtained from the Commission on Human Medicines (CHM). The MHRA agreed that sufficient measures had been taken to support the safe recruitment of further participants. See the press release here.
• The MHRA has removed guidelines from 8 June 2020 that suspended recruitment of participants for UK clinical trials that used hydroxychloroquine to treat or prevent COVID-19. See the updated webpage here.
• The relaxation of enforcement of the Veterinary Medicines Regulations (VMRs) during the COVID-19 outbreak has been extended to 31 July 2020 in respect of temporary change of premises, temporary changes to the retail supply of veterinary medicines and SQPs being temporarily permitted to prescribe and authorise the supply of veterinary medicines remotely.
• The MHRA has updated its guidance on how COVID-19 tests and testing kits work to add a ‘Target Product Profile’ document for Point of Care SARS-CoV-2 detection tests. See the document here.

June 25, 2020

• The Department of Health and Social Care (DHSC) has announced that approximately 10,000 people in care homes in England will be given repeat COVID-19 testing. These tests include: (i) swab tests, and (ii) blood antibody tests. This forms part of ‘Pillar 4’ of the government’s COVID-19 testing strategy. See the press release here.

June 23, 2020

• The Ministry of Defence has funded the development of a predictive sepsis test for coronavirus patients, which has the potential to predict whether patients will develop sepsis prior to any symptoms appearing. See the press release here.

June 22, 2020

• The government has announced a new saliva test for coronavirus, which does not require the use of a swab, and is to be piloted in Southampton with participants completing weekly tests at home. See the press release here.

June 21, 2020

• The government has proposed changes to the Enterprise Act 2002 which will allow the government to scrutinise certain foreign takeovers to ensure they do not threaten the UK’s ability to combat a public health emergency such as coronavirus. These new powers will enable the government to intervene if a business that is directly involved in a pandemic response, such as a vaccine research company or PPE manufacturer, finds itself the target of a takeover. See the press release here.

June 18, 2020

• The government has announced the next phase of development in building the app that will support the NHS COVID-19 Test and Trace service. See the press release here.

June 17, 2020

• The MHRA has updated its guidance on exemptions from the medical devices regulations during the COVID-19 outbreak to include three new bullet points at the bottom of the list of information to include in an email application for an exemption.

June 16, 2020

• The MHRA has suspended recruitment for clinical trials that use hydroxychloroquine to treat or prevent COVID-19. See the press release here.
• The government has authorised the NHS to use the world’s first COVID-19 treatment proven to reduce the risk of death. Dexamethasone, an anti-inflammatory drug, has been immediately approved to treat all UK hospitalised COVID-19 patients requiring oxygen, including those on ventilators. See the press release here.

June 15, 2020

• Clinical researchers will begin human trials of a new COVID-19 vaccine developed at Imperial College London. The Imperial College London vaccine has received £41 million in government funding. See the press release here.
• The DHSC and MHRA have updated the list of medicines that cannot be exported from the UK or hoarded because they are required for UK patients. Two pharmaceutical forms of dexamethasone (an oral solution and solution for injection) have been added to the list.

June 11, 2020

• On 3 June 2020, the DHSC issued guidance on how the government considers and assesses offers of serology and viral detection tests for national-level procurement to support the UK’s COVID-19 testing strategy.

June 8, 2020

• The MHRA has issued a medical device alert which states that results from laboratory-based tests for COVID-19 antibodies using capillary blood sample collection kits may not be reliable. The alert includes an action list for laboratories that offer a COVID-19 testing service for the public, private healthcare or NHS.

June 5, 2020

• The MHRA has updated its guidance on how tests and testing kits for COVID-19 work to include a Target Product Profile for enzyme immunoassay (EIA) antibody tests.
• The MHRA has published guidance on the regulatory status of software (including apps) used in the diagnosis, treatment and management of patients with COVID-19. There is separate advice for (i) manufacturers; and (ii) members of the public and professional users.
• The MHRA has updated its guidance on regulatory flexibilities resulting from COVID-19 to include information on audits of Notified Bodies and manufacturers in the ‘medical devices’ section. 

June 4, 2020

• The MHRA has issued guidance on 3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic. The requirements for manufacturing 3D printing will depend on whether the item is classed as a medical device or personal protective equipment (PPE).

May 29, 2020

• The MHRA has asked providers of laboratory-based COVID-19 antibody testing services to halt sales of the fingerprick COVID-19 antibody testing kits.
• The MHRA has updated the list of information it requires for an application for exemption from the medical devices regulations during the COVID-19 outbreak.
• The MHRA has updated its guidance on how tests and testing kits for COVID-19 work to include (i) information on temporarily stopping the sale of COVID-19 antibody tests for members of the public until regulatory and safety concerns are resolved; and (ii) new content on performance evaluation process for test kits.

May 28, 2020

• The UK has joined the global COVID-19 High Performance Computing (HPC) consortium, launched in the US. This is intended to rapidly accelerate the UK’s coronavirus research by providing researchers and scientists access to the world’s largest and fastest supercomputers. The UK’s access will be led by UK Research and Innovation (UKRI). See the press release here.

May 26, 2020

• The MHRA has given the first positive scientific opinion under the Early Access to Medicines Scheme (EAMS) to support the use of remdesivir to treat COVID-19. See the press release here.

May 21, 2020

• The MHRA has published guidance on immunomodulatory drugs in respect of pregnancy prevention arrangements during the COVID-19 outbreak.
• The MHRA has stated that Clinical Practice Research Datalink (CPRD), a research service jointly sponsored by the MHRA and NIHR, is making COVID-19 research a top priority by fast-tracking protocols for COVID-19 research.
• The NIHR has published a framework for restarting NIHR research activities which have been paused due to COVID-19.

May 20, 2020

• The MHRA has updated its guidance on regulatory flexibilities during the COVID-19 outbreak to include (i) a new section on making use of regulatory flexibilities; and (ii) new information on allowing pregnancy testing, as part of a pregnancy prevention plan (PPP), to be done remotely.
• The MHRA has added a document on the process for developing and evaluating novel molecular assays for COVID-19 to its guidance on tests and testing kits for COVID-19.

May 17, 2020

• The UK government has announced £84 million in funding to support the COVID-19 vaccine being developed at the University of Oxford and Imperial College London.
• The UK government has announced a £93 million investment to open the UK’s first dedicated Vaccine Manufacturing and Innovation Centre which is intended to boost the UK’s capacity to develop and mass produce vaccines. The new Centre is a key component of the government’s COVID-19 vaccine programme.
• The UK government has announced a large-scale study of COVID-19 immunity, tracking the spread of COVID-19 in the general population. The research will measure antibodies to help determine what proportion of the population has already had the infection, the duration of immunity after being infected, and why the virus affects people differently.

May 14, 2020

• The MHRA has updated its guidance to link to a National Institute for Biological Standards and Control (NIBSC) announcement that an antibody research reagent is now available for COVID-19. The new antibody reagent is plasma that has been treated to inactivate enveloped viruses and is derived from a donor that has recovered from COVID-19. It is intended to be used as a positive control for the development and evaluation of serological assays that detect the presence of antibodies against SARS-CoV-2.
• The Financial Times has reported that Public Health England (PHE) has approved a COVID-19 antibody test. The test correctly identified the presence of antibodies in 100% of affected blood samples in an independent evaluation carried out by PHE scientific experts. See the full article here.

May 13, 2020

• The MHRA has published guidance on how tests and testing kits for COVID-19 work, and the specifications for manufacturers. This update replaces the MHRA’s previous guidance on COVID-19 tests.
• The Department for Health and Social Care (DHSC) has announced a new genome sequencing study in the NHS which will involve up to 35,000 individuals with COVID-19. The project is backed by £28 million from Genomics England, UK Research and Innovation, the DHSC and the National Institute for Health Research (NIHR).

May 12, 2020

• The MHRA has updated its guidance on COVID-19 to add a new section linking to general government guidance for different workplaces: labs and research facilities; offices and contact centres; factories, plants and warehouses; and shops and branches.

May 7, 2020

• The MHRA has updated its guidance on regulatory flexibilities resulting from coronavirus to include new information on clinical investigations for devices, the relaxation of risk minimisation measures and flexibility in the reporting requirements for Individual Case Study Reports (ICSRs).
• The MHRA has updated its guidance on medical devices clinical investigations during the pandemic to include a new section on clinical investigations about COVID-19.

May 6, 2020

• The MHRA has issued temporary guidance for specialists for the initiation of valproate in female patients during the COVID-19 pandemic.
• The MHRA has announced that a new biological reagent is now available to labs around the UK and the world that will help them to develop accurate diagnostic tests for coronavirus. The reagent is non-infectious genetic material from SARS-CoV-2, the coronavirus responsible for the COVID-19 pandemic. See the press release here.

May 4, 2020

• The MHRA has launched a new Yellow Card reporting site dedicated to reporting any suspected side effects from medicines, future vaccines and incidents involving medical equipment relating to COVID-19 treatment. See the press release here.

May 1, 2020

• ABHI has reported that the UK government has this week written to suppliers reiterating the process established around supply distribution, and the importance of early notification to the National Supply Disruption Response (NSDR).

April 30, 2020

• The government has announced a major home testing programme for coronavirus which will track levels of infection in the community. 100,000 people will be sent self-testing kits to determine if they are currently infected. This will improve understanding of how many people are currently infected with the virus, and potentially how many have been infected and recovered since the outbreak began. See the press release here.
• The MHRA has compiled its latest guidance for medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme.

April 29, 2020

• The UK government has announced a rapidly scaled-up national initiative which means clinical trials for six potential COVID-19 treatments could start in weeks rather than months. The clinical trials form part of a national collaboration between government, academic and industry. See the press release here.
• The Veterinary Medicines Directorate (VMD) has relaxed the enforcement of specific provisions of the Veterinary Medicines Regulations (VMR) to allow veterinary surgeons to delegate the retail supply of veterinary medicines to internet retailers or wholesale dealers for home delivery to the end user. This decision has immediate effect and will initially last until 31 May when it will be reviewed. See the press release here.

April 28, 2020

• The MHRA has stated that it currently unable to proceed with any new applications to provide ventilators that have not already started. The UK has fulfilled the clinical need for ventilators through a combination of existing CE marked ventilators and existing applications to the Ventilator Challenge.

April 25, 2020

• The first UK clinical trial which will use plasma to treat COVID-19 patients has been approved. In parallel with the trial, the government is scaling up the national programme for collecting plasma so the treatment can be widely rolled out if it is shown to be effective. See the press release here.

April 24, 2020

• The MHRA has published a new version of the COVID-19 tests and testing kits specification.

April 23, 2020

• The UK government and the MHRA have updated the list of medicines that cannot be parallel exported from the UK. There are now 196 medicines on the list. 
• The MHRA has approved the COVID-19 Oxford Vaccine Trial in 7 working days. Scientists in Oxford started to design a vaccine in early January 2020, and are now ready to start the first clinical testing phase. The project is supported by a joint funding scheme between UK Research and Innovation (UKRI) and the National Institute for Health Research (NIHR). See the press release here.
• The UK government has started a large-scale virus infection and antibody test study. Up to 300,000 people are expected to take part over the next 12 months. See the press release here.

April 22, 2020

• Britain’s biggest network of diagnostic labs has been completed in 5 weeks. Sites in Milton Keynes, Glasgow and Alderley Park in Cheshire are now live and testing thousands of patient samples for COVID-19 each day. See the press release here.
• The MHRA has amended its clinical trials guidance to include content on accountability of investigational medicinal products and urgent safety measures. It has also updated its guidance around managing ongoing and halted trials, remote monitoring and signatures.
• The MHRA has issued guidance on exceptional GMP flexibilities for medicines manufacturers during the COVID-19 outbreak.

April 17, 2020

• The UK government has launched a Vaccine Taskforce intended to drive forward, expedite and co-ordinate efforts to research and produce a COVID-19 vaccine. See the press release here.

April 16, 2020

• The MHRA has updated its guidance on regulatory flexibilities to add a new section on Pharmacovigilance.
• The first newly-adapted design from the UK government’s Ventilator Challenge has received regulatory approval and is ready to for use in NHS hospitals. See the press release here.

April 14, 2020

• The MHRA has published updated guidance that reflects the European Parliament and European Council’s decision to delay the full implementation of the Medical Device Regulation by one year.
• The Commission of Human Medicines (CHM) Expert Working Group on coronavirus COVID-19 has concluded that there is currently insufficient evidence to establish a link between use of ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and susceptibility to contracting COVID-19 or the worsening of its symptoms.

April 10, 2020

• The Department of Health and Social Care has published a COVID-19 PPE plan which aims to ensure that critical PPE is delivered to those on the frontline responding to COVID-19. The plan incorporates three strands: (i) guidance; (ii) distribution; and (iii) future supply.

April 8, 2020

• The MHRA has released initial specifications for COVID-19 tests and testing kits.
• The MHRA has announced that for all anaesthesia machines with ventilators, using the anaesthesia device in treatment of critical illness outside its intended use is considered off-label use but may be essential due to ventilator availability.

April 7, 2020

• The Veterinary Medicines Directorate (VMD) has relaxed the enforcement of specific provisions of the Veterinary Medicines Regulations (VMR) to allow veterinary surgeons to delegate the retail supply of veterinary medicines to internet retailers or wholesale dealers for home delivery to the end user. See the press release here.

April 6, 2020

• The Department of Health and Social Care has published further technical specifications for PPE.

April 3, 2020

• The Department of Health and Social Care has announced the world’s largest randomised clinical trial of potential COVID-19 treatments is underway.

April 2, 2020

• The Department of Health and Social Care has stated that during the COVID-19 outbreak, anyone wishing to export personal protective equipment (PPE) to areas outside the EU, European Free Trade Association member states (Iceland, Liechtenstein, Norway, Switzerland) and certain other territories will temporarily require a PPE export license.

April 1, 2020

• The MHRA has published guidance on regulatory flexibilities resulting from the COVID-19 outbreak. The guidance includes clinical trials, inspections and good practice, medical devices and medicines regulation.

March 31, 2020

• The MHRA has issued guidance on exceptional GMP flexibilities for medicines imported from third countries during the COVID-19 outbreak.
• The MHRA has approved an adapted Continuous Positive Airway Pressure (CPAP) device that delivers oxygen to the lungs without needing a ventilator. The device was developed by a team of University College London (UCL) and Mercedes Formula One engineers and clinicians.
• HM Treasury has announced that the government is temporarily waiving import VAT and customs duty on vital medical equipment including ventilators, testing kits and protective clothing from outside the EU.

March 30, 2020

• The MHRA has published guidance on medical devices clinical investigations during the COVID-19 outbreak.

March 29, 2020

• The MHRA has published a specification for the Rapidly Manufactured Continuous Positive Airway Pressure (RMCPAP) system to be used in UK hospitals.

March 28, 2020

• The UK government has announced the temporary suspension of certain regulations to fast-track supplies of hand sanitiser and PPE to NHS staff.

March 26, 2020

• The MHRA has published guidance on the regulatory status of equipment being used to help prevent COVID-19, including hand sanitisers and gels, face masks and gloves.

March 25, 2020

• The MHRA has issued guidance on exemptions from the Medical Devices Regulations 2002 during the COVID-19 outbreak. The MHRA may authorise the supply of a non-CE marked device in the interest of the protection of health if the device has been approved by the Department of Health and Social Care.

March 24, 2020

• The MHRA has issued updated guidance for managing clinical trials during COVID-19.
• The UK professional regulating body for veterinarians (RCVS) has introduced temporary measures to relax rules for the supply of prescription only medicines to animals. To protect the safety veterinary personnel and the welfare of animals during the COVID-19 pandemic, veterinarians may now prescribe prescription only veterinary medicines remotely (without performing a clinical examination of the animal) where no other options are available. The position will be reviewed on an ongoing basis and in any event, no later than 30 June 2020.

March 23, 2020

• The British Veterinary Association has issued guidance to all UK veterinary practices to reduce face-to-face contact immediately and to reduce veterinary services to emergency care, the fulfilment of urgent prescriptions and maintaining the food supply-chain. This advice will remain in place for 3 weeks and will be reviewed in light of any further Government instructions.

March 20, 2020

• The MHRA has issued specifications for ventilators (the Rapidly Manufactured Ventilator System) to be used in UK hospitals during the COVID-19 outbreak. The guidance sets out the clinical requirements based on the consensus of what is ‘minimally acceptable’ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators.
• The MHRA has announced new arrangements for MHRA Good Practice (GxP) inspections due to COVID-19. It will only conduct essential inspections of Laboratories, Clinical Trials, Manufacturing, Distribution and Pharmacovigilance until further notice. 

March 19, 2020

• The MHRA has issued a form for regulatory approval of COVID-19 test kits. It is developing specifications for SARS-CoV-2 tests and will make these available as soon as possible.
• The MHRA has stated that it will prioritise and provide any assistance for clinical trials applications for COVID-19.

March 13, 2020

• The Department of Health and Social Care has written to suppliers informing them that the National Supply Disruption Response (NSDR) has been stood up to monitor the supply of medical products in light of COVID-19 and to provide resolution where possible. 

October 6, 2020

• Swissmedic, the Swiss Agency for Therapeutic Products, announced that on the beginning of October, AstraZeneca submitted an application for a marketing authorization for a Covid-19 vaccine. This application will be treated in a rolling-submission procedure, reserved for medicinal products that have not yet undergone all clinical trials requested for a marketing authorization. This rolling-submission procedure was only introduced by Swissmedic mid-September 2020 in order to speed up the review of innovative medicinal products for urgent public health needs. See the press release here.

April 3, 2020

The Swiss Federal Council, based on its emergency powers, issued Federal Ordinance #2 on Measures to Combat the Corona Virus (COVID-19-Ordinance-2); only available in GE/FR/IT; German version: https://www.newsd.admin.ch/newsd/message/attachments/60847.pdf). The Ordinance will come into force tomorrow, 4 April 2020.

The COVID-19-Ordinance-2 inter alia:

• confers further powers to the Swiss Confederation to coordinate the supply of important medical goods (e.g. personal protection equipment, listed medicinal products and medical devices) for combatting COVID-19 (important goods) to combat the corona virus
• obliges the cantons to report their current stocks of important goods
• enables the Federal Government to acquire important goods for the supply of the cantons
• subjects the export of important goods to a special authorization, issued by the State Secretariat for Economic Affairs (seco)
• enables the Federal Government to confiscate important goods and (re-)distribute them
• enables the Federal Government to obligate private enterprises to manufacture important goods or to prioritize the production of such goods

Furthermore, the COVID-19-Ordinance-2 contains important and far reaching changes to the current regulations of medicinal products:

New medicinal products containing certain active ingredients listed in annex 5 of the ordinance and are indicated for the treatment of COVID-19 patients may be put on the market without a Swiss marketing authorization (MA), only based on an application for a MA submitted to Swissmedic; the same goes for respective variations.

Swissmedic is generally authorized to deviate from the regulatory requirements (laid down in the Therapeutic Products Act and its ordinances) based on a benefit/risk analysis as far as such medicinal products are concerned. 

March 27, 2020

• The Swiss Society for Infectious Diseases has issued guidance on SARS-CoV-2-Specific antiviral treatment.

March 26, 2020

• Swissmedic and swissethics (the umbrella organisation of the cantonal ethics committees) have issued a common guidance on clinical trials on medicinal products in Switzerland during the COVID-19 pandemic, addressing both clinical trials with medicinal products for treating COVID-19 and challenges in ongoing clinical trials for other drugs. 

March 25, 2020

• Swissmedic has issued guidance (in German, French and Italian only) on autologous and family related blood and stem-cell donations. [25 March 2020]

March 24, 2020

• Swissmedic has issued guidance on exemptions from the Swiss Medical Devices Ordinance during the COVID-19 outbreak on the basis of the Federal Epidemics Act. Subject to certain conditions, Swissmedic may authorise exemptions for placing non-compliant medical devices, i.e., non-CE marked devices, on the market in the interest of the protection of health.

March 16, 2020

• Swissmedic has issued general information on medical devices in times of the COVID-19 pandemic, e.g., about protective masks and respirators, disposable gloves, hand sanitizers and COVID-19 tests.