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.
"David Fox is recognized for the quality of his strategic counsel on engagements with the FDA for 505 (b)(2) New Drug Applications. 'I would never do a pharmaceuticals deal without his involvement. His insights into FDA regulatory matters is unparalleled,' says one impressed source."
"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.'"
Areas of Focus
Life Sciences: Regulatory/Compliance
Healthcare: Pharmaceutical/Medical Products Regulatory
Healthcare: Life Sciences
Legal 500 U.S.
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
Who's Who Legal, 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?