FAQ: What You Need to Know About FDA Accelerated Approval, RMAT, IND Clearance, and the EU Centralized Procedure
Not all regulatory milestones are equal, and the differences can determine how fast a therapy reaches patients. Read this guide to 4 key FDA and EU pathways.
FDA accelerated approval is a regulatory pathway established in 1992 and codified under Section 506(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that enables approval of drugs for serious or life-threatening conditions. An accelerated approval is based on a surrogate or intermediate clinical endpoint that is reasonably likely to predict clinical benefit, rather than a direct measure of how a patient feels, functions, or survives.1 The 2023 Consolidated Appropriations Act strengthened the program by requiring sponsors to have a confirmatory trial underway at the time of approval and granting FDA enhanced authority to expedite withdrawal if post-marketing studies fail to verify benefit.2