FDA-TRACK: ADUFA Performance
Animal Drug Applications and Supplements
On August 14, 2018, the third reauthorization of the Animal Drug User Fee Act (ADUFA), referred to as ADUFA IV, was signed into law. ADUFA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing ADUFA for an additional five years (FY 2019 through FY 2023). 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 December 31, 2021. The ADUFA Dashboards present final performance in meeting ADUFA goals for FY 2020 and preliminary performance for FY 2021 and FY 2022 YTD (Q1). Final ADUFA performance data for FY 2021 will be presented in the FY 2022 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