Exploring FDA’s Expedited Programs: Applicability and Eligibility
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