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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Biosimilar User Fee Act Procedural Responses

 

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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 Procedural Responses Dataset

Footnotes:

  • * Performance is currently preliminary due to pending submissions.
  • ** New Performance Goal for BsUFA III with performance tracking beginning in FY23 (see Changes for this Goal, page 28).
  • *** New Performance Goal for BsUFA III with performance tracking beginning in FY24 (see Changes for this Goal, page 27).

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