FDA-TRACK: Animal Generic Drug User Fee Act (AGDUFA) Performance
Animal Generic Drug Applications and Supplements
On September 30, 2023, the third reauthorization of the Animal Generic Drug User Fee Act (AGDUFA), referred to as AGDUFA IV, was signed into law. AGDUFA IV amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing AGDUFA for an additional five years (FY 2024 through FY 2028). AGDUFA provides FDA with resources to enhance the performance and predictability of the generic new animal drug review process resulting in more readily available safe and effective new products.
The Animal Generic Drug User Fee Performance Dashboards (AGDUFA Dashboards) provide a concise, interactive, and visual presentation of data presented in the legislatively mandated AGDUFA Performance Report to Congress for the Animal Generic Drug User Fee Act (the Report). The AGDUFA Dashboards are not intended to replace the Report and are to be used as a supplemental tool for viewing the data. The AGDUFA Dashboards reflect performance on submissions received and actions taken as of December 31, 2023. The AGDUFA Dashboards present final performance in meeting AGDUFA goals for FY 2022 and preliminary performance for FY 2023 and FY 2024 YTD. Final AGDUFA performance data for FY 2023 will be presented in the FY 2024 AGDUFA Report and referenced in updated versions of the AGDUFA Dashboards.
Animal Generic Drug Applications and Supplements
The Animal Generic Drug Applications and Supplements Dashboard displays current performance relating to the review of:
- Original Abbreviated New Animal Drug Applications (ANADAs) and Reactivations
- Administrative ANADAs
- Manufacturing Supplemental ANADAs and Reactivations
- Generic Investigational New Animal Drug (JINAD) Study Submissions
- JINAD Protocol Submissions
- Initial JINAD Submissions