FDA-TRACK: Animal Drug User Fee Act (ADUFA) Performance
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.
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
Other Performance Goals
Beginning in fiscal year 2024, FDA will report quarterly data for:
- Investigational New Animal Drug (INAD) H Submissions submitted to the Office of New Animal Drug Evaluation at the Division Level
- INAD protocols without data and for INAD study submissions, the number of the following outcomes: (1) favorable, (2) non-concurrence/non-accepted but shortened review offered, and (3) non-concurrence/non-accepted and shortened review not offered
- Percentage of pre-approval inspection risk decisions which relied at least in part on information from inspections recognized under a mutual recognition agreement with a foreign regulatory authority