Exploring New FDA Initiatives

March 13, 2024 8:30am

Stacy Cline Amin
Partner
Morrison & Foerster
Former Chief Counsel, U.S. FDA

Kurt R. Karst
Director
Hyman, Phelps & McNamara, P.C. (Washington, DC)

This panel will discuss recent changes made to the Food Drug & Cosmetic Act by the FDA User Fee Reauthorization Act of 2022, and the Food and Drug Omnibus Reform Act of 2022 (FDORA), including new provisions for clinical trials and accelerated approval. In addition, the panel will highlight recent litigation against FDA and pending legislation of significance.