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  1. FDA-TRACK: Agency-wide Program Performance

FDA-TRACK: Animal Drug User Fee Act (ADUFA) Performance Reports

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On September 30, 2023, the fourth reauthorization of the Animal Drug User Fee Act (ADUFA) was signed into law. ADUFA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing ADUFA for an additional 5 years (FY 2024 through FY 2028, referred to as ADUFA V). ADUFA provides FDA with revenue to enhance the performance and predictability in review times for the animal drug industry and provide 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.

 

ADUFA I to ADUFA V

Since the implementation of ADUFA I in 2003, FDA has agreed to pursue a comprehensive set of review performance goals and commitments that seek to improve the timeliness and predictability of the review of new animal drug applications (NADAs) and investigational new animal drug (INAD) submissions.

  • ADUFA I: (FY 2004 to FY 2008). ADUFA I established review performance goals for FDA, phased in over a 5-year period. These performance goals ran from FY 2004 through FY 2008 and were intended to achieve progressive, yearly improvements in the process for review of NADAs. FDA agreed to review and act on submissions within shorter periods of time for each year. With increased resources under ADUFA I, FDA was able to commit to and achieve review performance goals that incrementally increased to 90 percent levels.
  • ADUFA II: (FY 2009 to FY 2013). Under ADUFA II, a key improvement has been the “end-review amendment” (ERA) process that allows FDA reviewers to work with the drug sponsor to amend certain pending submissions. The ERA process allows FDA to decrease the number of review cycles, ultimately leading to a shorter time for approvals.
  • ADUFA III: (FY 2014 to FY 2018). ADUFA III included comprehensive FDA review performance goals and commitments designed to improve the timeliness and predictability for review of NADAs, supplemental NADAs, and INAD submissions.
  • ADUFA IV: (FY 2019 to FY 2023). ADUFA IV includes a comprehensive set of FDA review performance goals and commitments designed to improve the timeliness and predictability of the review of new animal drug applications (NADAs) and reactivations, supplemental NADAs and reactivations, and investigational new animal drug (INAD) submissions. ADUFA IV also added new performance goals for validating tissue residue methods and scheduling pre-submission conferences, and reduce review times for two other measures as well as converting to all electronic submissions. Additionally, the reauthorization provides the commitment to implement the US-EU Good Manufacturing Practices Inspection Mutual Recognition Agreement, and provide an expanded pathway for conditional approval.
  • ADUFA V: (FY 2024 to FY 2028). ADUFA V advances FDA's animal drug review program by preserving established performance goals and international agreements while continuing to offer the expanded conditional approval pathway. The reauthorization emphasizes collaboration through five industry working groups addressing critical areas including ADAA combination medicated feeds, residue method trials, sentinel submission clock stop, product development plan feedback, and enhanced program metrics. Additionally, FDA committed to transparency measures, including publishing new program metrics, a third-party program assessment, publishing guidance on raw data submission expectations, and annual industry educational sessions.

Annual performance reports are prepared by the FDA's Performance Management Staff in collaboration with FDA’s Center for Veterinary Medicine (CVM).

ADUFA Performance Reports

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