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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: PDUFA Procedural Notifications and Responses

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 Procedural Notifications and Responses Dataset


  • * 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)

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