FDA Regulatory partner, George O’Brien will explore the “FDA’s Expedited Programs: Applicability and Eligibility” on March 19 at this year’s FDA Boot Camp hosted by ACI in New York. The panel will address:
- 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 and the status of the Rare Pediatric Disease Priority Review Voucher (expiring December 2024, pending the Give Kids a Chance Act of 2024)
- Factoring expedited programs into your drug development strategy
- Examining recent changes to FDA’s Accelerated Approval program
For more information and to register, please visit the event website.
