Exploring FDA’s Expedited Programs: Applicability and Eligibility

March 22, 2023 10:45am

Matt Hegreness
Partner (FDA Regulatory)
Covington & Burling LLP
(Washington, DC)

  • Distinguishing among the different FDA programs for expedited review, authorization 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