David M. Fox, JD

David Fox is a leading authority on the regulation of prescription and over-the-counter drugs, biological products, combination products, and controlled substances. 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 drug development, advising industry teams on gaining approval for novel products across numerous therapeutic classes, including respiratory, oncology, pain, addiction therapy, neurology and psychiatry, anti-infectives and anti-virals, vaccines and metabolic disorders. David is a graduate of the College of William and Mary (B.A. ’86) and NYU School of Law (J.D. ’89). He served as Assistant Chief of Enforcement and Associate Chief for Drugs in FDA’s Office of the Chief Counsel from 1994-2000.