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In this section: NDA and BLA Approvals

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 (September 30, 2024) (PDF - 396 KB)
CDER Drug and Biologic Restricted Distribution Approvals
CBER Drug and Biologic Accelerated Approvals Based on a Surrogate Endpoint (December 3, 2022) (PDF - 179 KB)

Related Information

Accelerated Approval Program

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