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David M. Fox

Partner
Washington, D.C.

David M. Fox

David M. Fox is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances.

He began his Food and Drug Administration (FDA) career in its Office of the Chief Counsel as assistant chief counsel for enforcement and associate chief counsel for drugs. During his FDA tenure and in private practice, David has been deeply involved in precedent-setting disputes between pioneer and generic drug sponsors under the Hatch-Waxman Act. In 2012, he founded biosimilarslawblog.com, a forum for commenting on the emerging field of biosimilars. He has also published leading texts on drug-device combination products and the regulation of controlled substances by FDA and Drug Enforcement Administration (DEA).

David advises management teams, from start-ups to the largest global pharmaceutical and biotechnology companies, on matters before the FDA and DEA. He is closely integrated with funding sources for the industry and is frequently retained as a strategic advisor on assessing the value of life sciences assets. He is known for his collaborative approach to complex regulatory issues and has successfully resolved numerous differences between sponsors and staff at FDA on products that raise novel issues.

Regularly recognized at the top of the administrative law bar, David was named the 2015 LMG Life Sciences Regulatory Lawyer of the Year. He is also routinely listed at the top of his field in leading industry publications, including Chambers USA America's Leading Lawyers, Who's Who Legal, Washington D.C. Super Lawyers, PLC Life Sciences, and Washingtonian's Top Lawyers.

David previously led our Pharmaceutical and Biotechnology Practice Group and now serves on the firm's Global Life Sciences Management Team.

"[R]egarded as one of the brightest all-round stars among the younger generation of FDA lawyers."

PLC Legal Life Sciences

Education and admissions

Education

  • J.D., New York University School of Law, 1989
  • B.A., The College of William & Mary, 1985

Bar admissions and qualifications

  • District of Columbia
  • New York

2017

Life Sciences

Who's Who Legal

2007-2011, 2014-2016

Life Sciences: Regulatory/Compliance

Chambers USA

2010-2011, 2014-2016

Healthcare: Pharmaceutical/Medical Products Regulatory

Chambers USA

2014-2015

Health

Chambers USA

2014

Healthcare: Life Sciences

Legal 500 U.S.

2013

FDA; Administrative Law, Intellectual Property, 2013-2014; Food and Drugs, 2014-2016

Washington, D.C. Super Lawyers

2009, 2011, 2013, 2014

Washington's Top Lawyers: Food and Drug

Washingtonian

2013

Most Highly Regarded Firms for Life Sciences

Who's Who Legal

2011-2012

Regulatory

PLC Life Sciences Cross-border Handbook

2007-2009

USA – Life Sciences: Regulatory, Recommended

PLC Which Lawyer?

 

FDA Award of Merit and Special Citation

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