Co-Chairs’ Opening Remarks

March 13, 2024 8:15am

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

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

Our co-chairs will delve into the 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, they will highlight recent litigation against FDA and pending legislation of significance.