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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 FDA’s Expedited Programs: Applicability and Eligibility
Jessica Tierney
Of Counsel
Jones Day
Benjamin Zegarelli
Of Counsel
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Distinguishing among the different FDA programs for expedited review and approval of drug products
- Evaluating the criteria for eligibility, benefits, and limitations of each program
- Understanding accelerated approval, surrogate and intermediate clinical endpoints
- Assessing the breakthrough therapy, regenerative medicine advance therapy (RMAT), and fast track designation programs
- Reviewing priority review
- Factoring expedited programs into your drug development strategy
- Examining recent changes to FDA’s Accelerated Approval program