Hogan Lovells US LLP

Pharmaceuticals and Biotechnology

Partner

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 U.S. Food and Drug Administration (FDA) and Drug Enforcement Administration. 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.

English

J.D., New York University School of Law, 1989; B.A., College of William & Mary, 1985