Mark I. Schwartz Esq.
Mark I. Schwartz Esq., director at Hyman, Phelps & McNamara, is the former deputy director of OCBQ, CBER. In a 13-year FDA career, Mark also worked closely CBER’s Division of Manufacturing and Product Quality and Division of Biological Standards and Quality Control and served as associate chief counsel of the FDA. Now in private practice, he advises clients on drug, biologic and device compliance, chemistry, manufacturing and control, and combination products, and has served as an expert witness in FDA-related litigation.
Communicating with the FDA: How to Facilitate an Inspection Post-COVID