David M. Fox

"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."

Chambers USA 2016

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.

Awards and recognitions

2018-2019

FDA Law
Best Lawyers in America

2007-2018

Life Sciences: Regulatory/Compliance (Nationwide)
Chambers USA

2010-2018

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

2013-2014, 2016-2018

Healthcare: Life Sciences, Leading Lawyer
Legal 500 US

2017

Life Sciences
Who's Who Legal

2013-2018

Selected to 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

Secretary's Award for Distinguished Service

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

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