Accelerated Approvals
These reports include accelerated and restricted approvals under Subpart H (drugs) and Subpart E (biologics).
Reports
- CDER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint (June 30, 2021) (PDF-257KB)
- CDER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint (Dec.31, 2020)
- CDER Drug and Biologic Restricted Distribution Approvals