Food, Drug and Medical Device Regulatory


Sidley’s Food, Drug and Medical Device Regulatory practice represents major pharmaceutical, biotechnology, medical device, food, cosmetic and tobacco product manufacturing clients all over the world. Our lawyers provide services in matters relating to the development, manufacture and marketing of products regulated by the Food and Drug Administration (FDA), the European Commission, China Food and Drug Administration (CFDA) and other related government authorities. This cutting-edge regulatory practice handles everything from product formulation and marketing authorization issues to postmarketing compliance, lifecycle management and significant enforcement matters.


“ ‘I don’t think it would be exaggeration to say that they have the most complete regulatory practice in the industry,’ declares one competitor about the team of attorneys at Sidley Austin. Another peer admires the firm for, ‘creating a truly complete practice that can deal with any issues a client may have, not just in the US, but all over the world as well.’ ”
LMG Life Sciences, 2013


Our Clients

Our client base is diverse, but united by a common thread: a commitment to engagement with product regulatory agencies that is both creative and pragmatic. LMG Life SciencesWe tackle the hardest regulatory problems by offering our clients solutions that account for not only direct risk but also the substantial relational capital at stake in all regulatory engagements, and the complex business realities that our clients face. Our portfolio is heavily weighted toward fully integrated, multinational, innovator pharmaceutical, biotechnology and medical device manufacturers, and we take a particular interest in development stage companies confronting regulatory issues for the first time. 


    “Sidley Austin LLP is, according to one client, ‘simply the best’ and, in FDA-related matters, ‘has few serious competitors’.”
    Legal 500 US, 2013


Our Approach

We confront our clients' most challenging regulatory issues by creating innovative, practical solutions that account for complicated business realities. We encourage a portfolio approach to risk management, involving careful discrimination among the many areas of regulatory ambiguity our clients face across specific franchises and the entire enterprise.

We remain attuned to changes in the regulatory environment driven by government agencies and media attention. Our lawyers assist clients in responding to the ever-changing legislative authorities possessed by key regulators, their greater attention to enforcement and the slowdown in product approvals by providing pivotal legal and regulatory arguments and strategic advice. At the same time, we are acutely aware of the differences between matters in which lawyers properly occupy a central role and those more appropriately handled primarily by scientists and regulatory affairs personnel. We discourage any over-involvement of legal professionals that would be contrary to our clients’ best interests.


Sidley was named by The National Law Journal as a finalist in the Washington Litigation Department of the Year 2014. As described by The NLJ, “Sidley Austin’s Washington litigators excel at melding regulatory expertise with litigation savvy to deliver results in a wide range of cases.”
The National Law Journal


Our Service

From clinical trials and marketing authorizations to post market safety, our lawyers help clients with the full range of regulatory issues they confront at every stage of the product life cycle. We assist clients on strategies and government interactions relating to:

  • Marketing Authorization Strategies;
  • Clinical Trial Development;
  • Promotional Practices;
  • Post-Marketing Safety Plans;
  • Product Classifications; and
  • Multi-Continent Regulatory Initiatives.

We also focus on products and technologies that are subject to rapidly evolving and complex regulatory requirements, including new in vitro diagnostic devices, combination products and software.

For consumer products companies, we combine substantial experience with both regulatory and enforcement matters relating to FDA, FTC, Lanham Act, and state consumer fraud law requirements. Our labeling, monograph and substantiation reviews, defense of investigations and product launch advice address these interdisciplinary concerns in an integrated way.

In the food arena, our team helps navigate regulatory pathways for medical foods, foods for special dietary use, conventional foods, dairy products and dietary supplements, and has represented both major finished product and ingredient suppliers on a number of regulatory issues on three continents. Safety determinations for dietary supplements and foods are an important part of our team's work.

Another major focus of our practice involves regulatory due diligence in connection with transactions. Our lawyers assist equity investors, lenders and acquiring companies in evaluating opportunities in all life sciences sectors and assist clients in conducting regulatory due diligence, thereby enabling comprehensive risk assessments.

Further, our practice focuses on issues arising under the Hatch-Waxman Act, such as market exclusivity periods, patent listing and certification requirements, 505(b)(2) issues and bioequivalence standards. In addition to Hatch-Waxman exclusivity, we also focus on obtaining and protecting market exclusivity related to orphan drugs and pediatric studies. We have been deeply involved in biosimilar issues and BPCIA implementation as well. Our FDA regulatory lawyers work closely with our patent and antitrust lawyers to provide an integrated approach to important life cycle management issues.  


“Sidley Austin is recognized as a leading firm for FDA regulatory work…”
Chambers USA, 2011 


Our Team

A number of our lawyers and professionals have worked at government agencies in various senior positions, including:

  • Acting Chief Counsel/Deputy Chief Counsel of FDA
  • Health Policy Advisor to the Senate Committee of Health, Education, Labor and Pensions (HELP)
  • Staff Attorney/Special Assistant to the Chief Counsel of FDA
  • Counselor in the Office of the Commissioner at the FDA, previously the Deputy Director for Policy in the Center for Devices and Radiological Health, FDA
  • Special Assistant United States Attorney
  • Legislative Counsel and Parliamentarian to the House Energy and Commerce Committee
  • Assistant Commissioner at the FDA
  • Head of the FDA Special Prosecution Task Force
  • a member of the European Commission’s Legal Service with responsibility for review of all food-and drug-related proposals
  • Legal Officer in the European Commission’s Directorate General for Health and Consumers

Sidley also has U.S.-qualified physicians, a Ph.D. geneticist, a doctor of law and a former quality control microbiologist.

Achievements 

  • Sidley won four awards, including the biggest honor of the evening “Life Cycle Firm of the Year” at the annual Legal Media Group Life Sciences Awards held on September 14, 2016. In addition, Sidley won “Regulatory Firm of the Year” for the fourth consecutive year. 
  • In 2016, for the sixth consecutive year, Sidley received the most first-tier national rankings in the U.S. News – Best Lawyers® “Best Law Firms” rankings, including FDA Law and Biotechnology Law. Sidley also received first-tier rankings in FDA Law and Biotechnology Law in Washington, D.C., and a first-tier ranking in Biotechnology Law in San Francisco.
  • Sidley was named one of Law360’s Life Sciences Practice Groups of the Year for 2015.
  • In 2016, The Legal 500 US ranked Sidley in its top tier for Healthcare: Life Sciences for the fifth consecutive year.
  • Since 2008, Sidley has continuously been recognized by Chambers Global and Chambers USA in its Global Life Sciences and National Life Sciences rankings. Sidley also received national and state rankings in two specific life sciences regulatory disciplines: Life Sciences: Regulatory and Compliance and Healthcare: Pharmaceutical/Medical Products Regulatory.
  • 37 lawyers from Sidley’s Beijing, Brussels, Chicago, Los Angeles, New York, Shanghai, Sydney, Tokyo and Washington, D.C. offices are recognized in the 2016 edition of Who’s Who Legal: Life Sciences.
  • In the fourth edition of Euromoney’s LMG Life Sciences 2015, Sidley is again one of ten Life Cycle firms and received the highest rankings (Highly Recommended) in 11 practice areas, including FDA – Pharmaceutical, FDA – Medical Devices, General Patent Litigation and Government Investigation/Fraud & Abuse. 
  • Sidley’s leading practice in the European life sciences sector is recognized in the 2015 edition of Euromoney’s LMG Life Sciences Europe, where Sidley is also featured as one of ten Pan-European firms, eight Sidley lawyers are featured as “Life Science Stars” and seven practice areas are ranked including Regulatory.
  • Sidley was named by The National Law Journal as a finalist for the Washington Litigation Department of the Year 2014. As described by The NLJ, “Sidley Austin’s Washington litigators excel at melding regulatory expertise with litigation savvy to deliver results in a wide range of cases.”

Sidley’s Food, Drug and Medical Device Regulatory practice represents major pharmaceutical, biotechnology, medical device, food, cosmetic and tobacco product manufacturing clients all over the world. Our lawyers provide services in matters relating to the development, manufacture and marketing of products regulated by the Food and Drug Administration (FDA), the European Commission, China Food and Drug Administration (CFDA) and other related government authorities. This cutting-edge regulatory practice handles everything from product formulation and marketing authorization issues to postmarketing compliance, lifecycle management and significant enforcement matters.


“ ‘I don’t think it would be exaggeration to say that they have the most complete regulatory practice in the industry,’ declares one competitor about the team of attorneys at Sidley Austin. Another peer admires the firm for, ‘creating a truly complete practice that can deal with any issues a client may have, not just in the US, but all over the world as well.’ ”
LMG Life Sciences, 2013


Our Clients

Our client base is diverse, but united by a common thread: a commitment to engagement with product regulatory agencies that is both creative and pragmatic. LMG Life SciencesWe tackle the hardest regulatory problems by offering our clients solutions that account for not only direct risk but also the substantial relational capital at stake in all regulatory engagements, and the complex business realities that our clients face. Our portfolio is heavily weighted toward fully integrated, multinational, innovator pharmaceutical, biotechnology and medical device manufacturers, and we take a particular interest in development stage companies confronting regulatory issues for the first time. 


    “Sidley Austin LLP is, according to one client, ‘simply the best’ and, in FDA-related matters, ‘has few serious competitors’.”
    Legal 500 US, 2013


Our Approach

We confront our clients' most challenging regulatory issues by creating innovative, practical solutions that account for complicated business realities. We encourage a portfolio approach to risk management, involving careful discrimination among the many areas of regulatory ambiguity our clients face across specific franchises and the entire enterprise.

We remain attuned to changes in the regulatory environment driven by government agencies and media attention. Our lawyers assist clients in responding to the ever-changing legislative authorities possessed by key regulators, their greater attention to enforcement and the slowdown in product approvals by providing pivotal legal and regulatory arguments and strategic advice. At the same time, we are acutely aware of the differences between matters in which lawyers properly occupy a central role and those more appropriately handled primarily by scientists and regulatory affairs personnel. We discourage any over-involvement of legal professionals that would be contrary to our clients’ best interests.


Sidley was named by The National Law Journal as a finalist in the Washington Litigation Department of the Year 2014. As described by The NLJ, “Sidley Austin’s Washington litigators excel at melding regulatory expertise with litigation savvy to deliver results in a wide range of cases.”
The National Law Journal


Our Service

From clinical trials and marketing authorizations to post market safety, our lawyers help clients with the full range of regulatory issues they confront at every stage of the product life cycle. We assist clients on strategies and government interactions relating to:

  • Marketing Authorization Strategies;
  • Clinical Trial Development;
  • Promotional Practices;
  • Post-Marketing Safety Plans;
  • Product Classifications; and
  • Multi-Continent Regulatory Initiatives.

We also focus on products and technologies that are subject to rapidly evolving and complex regulatory requirements, including new in vitro diagnostic devices, combination products and software.

For consumer products companies, we combine substantial experience with both regulatory and enforcement matters relating to FDA, FTC, Lanham Act, and state consumer fraud law requirements. Our labeling, monograph and substantiation reviews, defense of investigations and product launch advice address these interdisciplinary concerns in an integrated way.

In the food arena, our team helps navigate regulatory pathways for medical foods, foods for special dietary use, conventional foods, dairy products and dietary supplements, and has represented both major finished product and ingredient suppliers on a number of regulatory issues on three continents. Safety determinations for dietary supplements and foods are an important part of our team's work.

Another major focus of our practice involves regulatory due diligence in connection with transactions. Our lawyers assist equity investors, lenders and acquiring companies in evaluating opportunities in all life sciences sectors and assist clients in conducting regulatory due diligence, thereby enabling comprehensive risk assessments.

Further, our practice focuses on issues arising under the Hatch-Waxman Act, such as market exclusivity periods, patent listing and certification requirements, 505(b)(2) issues and bioequivalence standards. In addition to Hatch-Waxman exclusivity, we also focus on obtaining and protecting market exclusivity related to orphan drugs and pediatric studies. We have been deeply involved in biosimilar issues and BPCIA implementation as well. Our FDA regulatory lawyers work closely with our patent and antitrust lawyers to provide an integrated approach to important life cycle management issues.  


“Sidley Austin is recognized as a leading firm for FDA regulatory work…”
Chambers USA, 2011 


Our Team

A number of our lawyers and professionals have worked at government agencies in various senior positions, including:

  • Acting Chief Counsel/Deputy Chief Counsel of FDA
  • Health Policy Advisor to the Senate Committee of Health, Education, Labor and Pensions (HELP)
  • Staff Attorney/Special Assistant to the Chief Counsel of FDA
  • Counselor in the Office of the Commissioner at the FDA, previously the Deputy Director for Policy in the Center for Devices and Radiological Health, FDA
  • Special Assistant United States Attorney
  • Legislative Counsel and Parliamentarian to the House Energy and Commerce Committee
  • Assistant Commissioner at the FDA
  • Head of the FDA Special Prosecution Task Force
  • a member of the European Commission’s Legal Service with responsibility for review of all food-and drug-related proposals
  • Legal Officer in the European Commission’s Directorate General for Health and Consumers

Sidley also has U.S.-qualified physicians, a Ph.D. geneticist, a doctor of law and a former quality control microbiologist.

Achievements 

  • Sidley won four awards, including the biggest honor of the evening “Life Cycle Firm of the Year” at the annual Legal Media Group Life Sciences Awards held on September 14, 2016. In addition, Sidley won “Regulatory Firm of the Year” for the fourth consecutive year. 
  • In 2016, for the sixth consecutive year, Sidley received the most first-tier national rankings in the U.S. News – Best Lawyers® “Best Law Firms” rankings, including FDA Law and Biotechnology Law. Sidley also received first-tier rankings in FDA Law and Biotechnology Law in Washington, D.C., and a first-tier ranking in Biotechnology Law in San Francisco.
  • Sidley was named one of Law360’s Life Sciences Practice Groups of the Year for 2015.
  • In 2016, The Legal 500 US ranked Sidley in its top tier for Healthcare: Life Sciences for the fifth consecutive year.
  • Since 2008, Sidley has continuously been recognized by Chambers Global and Chambers USA in its Global Life Sciences and National Life Sciences rankings. Sidley also received national and state rankings in two specific life sciences regulatory disciplines: Life Sciences: Regulatory and Compliance and Healthcare: Pharmaceutical/Medical Products Regulatory.
  • 37 lawyers from Sidley’s Beijing, Brussels, Chicago, Los Angeles, New York, Shanghai, Sydney, Tokyo and Washington, D.C. offices are recognized in the 2016 edition of Who’s Who Legal: Life Sciences.
  • In the fourth edition of Euromoney’s LMG Life Sciences 2015, Sidley is again one of ten Life Cycle firms and received the highest rankings (Highly Recommended) in 11 practice areas, including FDA – Pharmaceutical, FDA – Medical Devices, General Patent Litigation and Government Investigation/Fraud & Abuse. 
  • Sidley’s leading practice in the European life sciences sector is recognized in the 2015 edition of Euromoney’s LMG Life Sciences Europe, where Sidley is also featured as one of ten Pan-European firms, eight Sidley lawyers are featured as “Life Science Stars” and seven practice areas are ranked including Regulatory.
  • Sidley was named by The National Law Journal as a finalist for the Washington Litigation Department of the Year 2014. As described by The NLJ, “Sidley Austin’s Washington litigators excel at melding regulatory expertise with litigation savvy to deliver results in a wide range of cases.”
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