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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Animal Drug User Fee Act Performance - Mutual Recognition Agreements

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.

Beginning in FY 2024, FDA will report quarterly in FDA‐TRACK the percentage of pre-approval inspection risk decisions in which enacted mutual recognition agreements were used to establish or to provide a more recent Good Manufacturing Practices history. FDA uses a risk-based approach to determine whether pre-approval inspections are needed to support submission approval using information provided in applications and information FDA may have regarding the facilities.

Risk factors include product risk (critical quality attributes (CQA)s, and the products context of use) and manufacturing risk (impact of the process on CQAs and facility capability and history). Pre-approval inspection decisions also consider the need to confirm accuracy and reliability of the information provided in the application or to verify on-site conformance to the application.

Download FDA-TRACK: ADUFA Performance - Mutual Recognition Agreements Dataset

Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.


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