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13/03/2024 14/03/2024 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2024
SpringHill Suites NY Manhattan Times Square South, New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. SpringHill Suites NY Manhattan Times Square South, New York, NY true DD/MM/YYYY 1440 use-title -
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13/03/2024 14/03/2024 America/Toronto FDA Boot Camp FDA Boot Camp
March 13 – 14, 2024
SpringHill Suites NY Manhattan Times Square South, New York, NY
Please visit https://www.americanconference.com/fda-boot-camp/ for more information and updates. SpringHill Suites NY Manhattan Times Square South, New York, NY true DD/MM/YYYY 1440 use-title -
Co-Chairs’ Opening Remarks
Stacy Cline Amin
Partner
Morrison & Foerster
Former Chief Counsel, U.S. FDA
Kurt R. Karst
Director
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.