U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Transparency
  4. FDA-TRACK: Agency-wide Program Performance
  5. FDA-TRACK: Prescription Drug User Fee Act Procedural Notifications and Responses
  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Prescription Drug User Fee Act Procedural Notifications and Responses

 

Subscribe to FDA-TRACK Updates

 

FDA-TRACK: CDER
FDA-TRACK: Biologics
PDUFA Performance Dashboard User Guide
FDA-TRACK Home Page

Prescription Drug Applications and Supplements

Procedural Notifications and Responses

Meeting
Management

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2017 (PDUFA VI), authorizes FDA to assess and collect fees for prescription drug products from October 2017 through September 2022. FDA dedicates these fees toward expediting the drug development process and the process for the review of human drug applications, including postmarket drug safety activities.

Download PDUFA Procedural Notifications and Responses Dataset

Footnotes:

  • * Performance is currently preliminary due to pending submissions.
  • ** New Performance Goal for PDUFA VI with performance tracking beginning in FY19 (see Changes for this Goal, page 25)

Sign up to receive FDA-TRACK updates

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top