Exploring FDA’s Expedited Programs: Applicability and Eligibility

March 13, 2024 10:45am

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