FDA-TRACK: AGDUFA Performance
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 June 30, 2022. The AGDUFA Dashboards present final performance in meeting AGDUFA goals for FY 2020 and preliminary performance for FY 2021 and FY 2022 YTD (Q3). Final AGDUFA performance data for FY 2021 will be presented in the FY 2022 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