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  5. FDA-TRACK: Prescription Drug User Fee Act Historical Performance - Prescription Drug Applications and Supplements
  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Prescription Drug User Fee Act Historical Performance - Prescription Drug Applications and Supplements

 

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Prescription Drug Applications and Supplements

Procedural Notifications and Responses

Meeting
Management

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Act of 2022 (PDUFA VII), authorizes FDA to assess and collect fees for prescription drug products from October 2023 through September 2027. 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: Prescription Drug Applications and Supplements Dataset

Footnotes:

  •   * Performance is currently preliminary due to pending submissions.
  • ** Beginning in PDUFA VII, Class 1 and 2 Resubmitted Original Applications are consolidated into one performance goal. To review the number filed, on time, and overdue for Class 1 and Class 2 resubmitted applications separately, please refer to the most recent PDUFA Performance Report (See Changes for this Goal, footnote 3, page 6).
  • *** The most recent FY workload and performance data includes applications that are identified as undesignated, which means they are still within the 60-day filing date and have not yet had a review designation, standard or priority, made.
  • **** Beginning in PDUFA VII, Class 1 and 2 Resubmitted Efficacy Supplements are consolidated into one performance goal. To review the number filed, on time, and overdue for Class 1 and Class 2 resubmitted efficacy supplements separately, please refer to the most recent PDUFA Performance Report (See Changes for this Goal, footnote 4, page 6).

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