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FDA outlines rescission of Breakthrough Therapy Designation
28 June 2022
PartnerWashington, D.C.
Email [email protected]hoganlovells.com
Phone +1 202 637 5600
Fax +1 202 637 5910
Practice groupGlobal Regulatory
"David Fox is a go-to attorney for clients bringing new products through review, as well as advising on related IP issues."
Chambers USA
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 served on the firm's global Life Sciences management team.
During his FDA tenure, David received the Secretary’s Award of Merit and an FDA Special Citation for his work on the FDA Tobacco Rule. David is a founding member of the Kitalys Institute to support interventions that delay the onset of diseases of aging, and David is on the Advisory Board of the Cancer Support Community. David also serves as pro bono counsel on a variety of programs to improve patient and care-giver welfare.
Life Sciences: Regulatory/Compliance (Nationwide)
Chambers USA
Life Sciences: Regulatory/Compliance (USA)
Chambers Global
Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia)
Chambers USA
Life Sciences Hall of Fame
LMG Life Sciences
FDA Law
Best Lawyers in America
Healthcare: Life Sciences, Hall of Fame
Legal 500 US
Healthcare: Life Sciences, Leading Lawyer
Legal 500 US
Life Sciences
Who's Who Legal
Selected to Super Lawyers
Washington's Top Lawyers: Food and Drug
Washingtonian
Most Highly Regarded Firms for Life Sciences
Who's Who Legal
Regulatory
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
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
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