Accelerated Approvals
These reports include accelerated and restricted approvals under Subpart H (drugs) and Subpart E (biologics) and will be updated quarterly in January, April, July, and October of each year.
Reports
- CDER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint (June 30, 2022) (PDF - 335KB)
- CDER Drug and Biologic Restricted Distribution Approvals