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  5. FDA-TRACK: Animal Drug User Fee Act (ADUFA) Performance
  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Animal Drug User Fee Act (ADUFA) Performance

On September 30, 2023, the fourth reauthorization of the Animal Drug User Fee Act (ADUFA), referred to as ADUFA V, was signed into law. ADUFA V amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing ADUFA for an additional five years (FY 2024 through FY 2028). ADUFA provides FDA with revenue to enhance the performance and predictability in review times for the animal drug industry and provides FDA with resources to improve its review of applications for new animal drugs, with the result that safe and effective new products will be more readily available.

The Animal Drug User Fee Performance Dashboards (ADUFA Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated ADUFA Performance Report to Congress for the Animal Drug User Fee Act (the Report). The ADUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The ADUFA Dashboards reflect performance on submissions received and actions taken as of March 31, 2024. The ADUFA Dashboards present final performance in meeting ADUFA goals for FY 2022 and preliminary performance for FY 2023 and FY 2024 YTD. Final ADUFA performance data for FY 2023 will be presented in the FY 2024 ADUFA Report and referenced in updated versions of the ADUFA Dashboards.

FDA-Track: ADUFA Drug Applications and Supplements

Animal Drug Applications and Supplements

The Animal Drug Applications and Supplements Dashboard displays current performance relating to the review of:

  • Original New Animal Drug Applications (NADAs) and Reactivations
  • Administrative NADAs
  • Non-Manufacturing Supplemental NADAs and Reactivations
  • Manufacturing Supplemental NADAs and Reactivations
  • Labeling Supplements
  • Investigational New Animal Drug (INAD) Study Submissions
  • INAD Protocol Submissions
  • Presubmission Conference
  • Tissue Residue Method Demonstrations

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