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David M. Fox

Washington, D.C.

David M. Fox

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

He advises management teams, from start-ups to the largest global pharmaceutical and biotechnology companies, on matters before the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA). David 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. Known for his collaborative approach to complex regulatory issues, David has successfully resolved numerous disputes between sponsors and staff at FDA on products that raise novel regulatory issues. As a former senior lawyer for FDA and throughout his career in private practice, David has been deeply immersed in the regulatory side of the Hatch-Waxman Act, including pioneer-generic disputes and numerous cases of first impression involving exclusivity issues, Orange Book listings and patent term extensions.

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

"David is praised by clients for his 'unsurpassed knowledge' particularly in the fields of Hatch-Waxman and pharmaceutical life cycle management. He is also commended by observers for his 'technical expertise, knowledge, counsel and insight.'"

Chambers 2015

Education and admissions


  • 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



Best Lawyers in America


Life Sciences: Regulatory/Compliance (Nationwide)

Chambers USA


Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia)

Chambers USA

2013-2014, 2016-2017

Healthcare: Life Sciences, Leading Lawyer

Legal 500 US


Life Sciences

Who's Who Legal


Food and Drugs

Washington, D.C. Super Lawyers

2009, 2011, 2013, 2014

Washington's Top Lawyers: Food and Drug



Most Highly Regarded Firms for Life Sciences

Who's Who Legal



PLC Life Sciences Cross-border Handbook


USA – Life Sciences: Regulatory, Recommended

PLC Which Lawyer?


FDA Award of Merit and Special Citation


Secretary's Award for Distinguished Service

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