News
Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules
28 October 2020
David M. Fox
PartnerWashington, D.C.
Email david.fox@hoganlovells.com
Phone +1 202 637 5678
Fax +1 202 637 5910
Practice groupGlobal Regulatory
"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
2007-2020
Life Sciences: Regulatory/Compliance (Nationwide)
Chambers USA
2020
Life Sciences: Regulatory/Compliance (USA)
Chambers Global
2020
Life Sciences Hall of Fame
LMG Life Sciences
2010-2020
Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia)
Chambers USA
2018-2019
FDA Law
Best Lawyers in America
2019-2020
Healthcare: Life Sciences, Hall of Fame
Legal 500 US
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., College of William & Mary, 1985
Bar admissions and qualifications
District of Columbia
New York
Latest thinking and events
Awards and Rankings
LMG Life Sciences recognizes Hogan Lovells as Regulatory Firm of the Year for third year in a row 2020
24 September 2020
Awards and Rankings
Global law firm Hogan Lovells is pleased to announce the firm has been shortlisted in 11 categories for the eighth Annual LMG Life Sciences Americas Awards 2020
10 August 2020
Insights
FDA Guidance on Combination Product Agreement Meetings lacks specificity, comments say
Registered Content
18 March 2020
Insights
“Misleading” to suggest a biosimilar is inferior, FDA draft guidance warns
Registered Content
05 February 2020
Insights
FDA issues draft guidance regarding “sameness” for Orphan Drug gene therapies
Registered Content
31 January 2020
