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  1. FDA-TRACK: Agency-wide Program Performance

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

 

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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). Two new categories of BPD Type 2 (i.e., BPD Type 2a and BPD Type 2b) were created under BsUFA III. Therefore, when doing a trend analysis comparing BPD Type 2 data from the most recent fiscal year to the previous fiscal years, it is important to include both BPD Type 2a and BPD Type 2b meeting categories. 
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