Exploring FDA’s Expedited Programs: Applicability and Eligibility
George O’Brien
FDA Partner
Mayer Brown LLP
- 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