An official website of the United States government Here’s how you know

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

In this section: NDA and BLA Approvals

Fast Track Approvals

Reports are in the FDA Archive

The CDER Fast Track (FT) Approvals reports contain a list of approvals for fast track designated drugs. New reports will be published in January, April, July, and October of each year (quarterly) as of 6-30-22.

Approvals

CDER FT Approvals (as of December 31, 2024) (PDF - 151 KB)
Previous Cumulative CY CDER FT Approvals (PDF - 335 KB)

Related Information

Top