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13/03/2025 14/03/2025 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2025
New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. New York, NY true DD/MM/YYYY 1440 use-title -
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13/03/2025 14/03/2025 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2025
New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. New York, NY true DD/MM/YYYY 1440 use-title -
Exploring New FDA Initiatives
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.