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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: PDUFA Prescription Drug Applications and Supplements

 

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FDA-TRACK: CDER
FDA-TRACK: Biologics
PDUFA Performance Dashboard User Guide
FDA-TRACK Home Page

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 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 Prescription Drug Applications and Supplements Dataset

Footnotes:

  •   * Performance is currently preliminary due to pending submissions.
  • ** 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.

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