Exploring FDA’s Expedited Programs: Applicability and Eligibility
Colleen M. Heisey
Partner
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