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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: PDUFA Historical Performance - Meeting Management

Prescription Drug Applications and Supplements

Procedural Notifications and Responses


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 Historical Performance: Meeting Management Dataset


  • * Performance is currently preliminary due to pending submissions.
  • ** New Performance Goal for PDUFA VI (see Changes for this Goal, pages 16-20)

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