FDA Accelerated Approval
Statutory
Description & Eligibility
US pathway allowing approval of drugs for serious conditions based on a surrogate endpoint reasonably likely to predict clinical benefit, with required confirmatory trials.
Legal Reference / Source
21 CFR 314 Subpart H
FDA Accelerated Approval
| Legal Status | Statutory |
| Source Ref. | 21 CFR 314 Subpart H |
| Countries | 0 countries |
Compliance Check
Legal Review7/24/2026
Global ValidityVerified