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

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.

U.S. Food and Drug Administration
  1. Home
  2. About FDA
  3. Performance Data
  4. FDA-TRACK: Agency-wide Program Performance
  5. FDA-TRACK: Biosimilar User Fee Act Historical Performance - Meeting Management
  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Biosimilar User Fee Act Historical Performance - Meeting Management

 

 

Subscribe to FDA-TRACK Updates

 

FDA-TRACK: Drugs
FDA-TRACK: Biologics
BsUFA Performance Dashboard User Guide
FDA-TRACK Home

Biosimilar Applications and Supplements

Procedural Notifications

Procedural Responses

Meeting
Management

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.

Download BsUFA Historical Performance: Meeting Management Dataset

Footnotes:

  • * Performance is currently preliminary due to pending submissions.
  • ** New Performance Goal for BsUFA III (see Changes for this Goal, pages 18 -23).
Back to Top