On March 31, 2020, the U.S. Food and Drug Administration (FDA) announced a new program to expedite the development of potentially safe and effective treatments for COVID-19. According to FDA, the Coronavirus Treatment Acceleration Program (CTAP) will use every tool at the agency’s disposal to bring new therapies to patients infected with COVID-19 while ensuring that those therapies are safe and effective.1
Under the program, staff from FDA’s Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are providing guidance, technical assistance and regulatory advice as quickly as possible to entities proposing treatments for COVID-19. For example, FDA states that it has already begun study protocols within 24 hours and has reviewed single-patient expanded access requests within three hours.2
Support for CTAP comes from redeployed medical and regulatory staff who have formed review teams dedicated to COVID-19 therapies. Senior management at FDA is involved in review of submissions. In addition, the agency has streamlined processes for developers and scientists to send inquiries and requests to FDA and is providing resources to healthcare providers to assist in the submissions of emergency requests for use of investigational products.3
FDA will continue to update and expand CTAP. As of April 2, FDA reports that there are ten therapeutic agents in active trials, and fifteen therapeutic agents in planning stages.4
1See FDA News Release, Coronavirus (COVID-19) Update: FDA Continues to Accelerate Development of Novel Therapies for COVID-19 (Mar. 31, 2020), https://bit.ly/2X0oHBy.
Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship.
Attorney Advertising - For purposes of compliance with New York State Bar rules, our headquarters are Sidley Austin LLP, 787 Seventh Avenue, New York, NY 10019, 212.839.5300; One South Dearborn, Chicago, IL 60603, 312.853.7000; and 1501 K Street, N.W., Washington, D.C. 20005, 202.736.8000.