FDA to Hold Virtual Public Meeting Explaining Key Takeaways from ADUFA Third-Party Assessment Report
September 23, 2025
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) has posted the ADUFA V Third-Party Assessment Report and has opened registration for a virtual public meeting to be held on October 30, 2025. The virtual public meeting will provide an overview of a third-party assessment report that examines the implementation of the Animal Drug User Fee Act (ADUFA).
In 2023, during negotiations for the reauthorization of ADUFA, CVM and stakeholders from the animal drug industry agreed that the agency would engage an independent third-party to conduct a comprehensive assessment of the ADUFA program and the process for the review of animal drug applications. This agreement is discussed in the ADUFA V Goals Commitment Letter.
The assessment evaluated the effectiveness of the ADUFA program from FY 2009 to FY 2022, including the review process, the tools used to improve efficiency, and the allocation of available resources. It consisted of stakeholder interviews with CVM and Industry personnel, a comprehensive review of CVM system records and performance data, and an examination of the activities in the review process. The assessment was conducted during calendar year 2024.
To learn more about this virtual-only event, please visit: https://events.gcc.teams.microsoft.com/event/0c499308-1f4e-49ef-8c23-a3d3b0712963@7d2fdb41-339c-4257-87f2-a665730b31fc
Registration is free but limited to 1000 participants. People interested in attending this virtual public meeting must register by 11:59 pm ET on October 29, 2025. We will inform registrants if the limit of 1000 is reached, at which point we will no longer be able to accommodate additional participants. Information on requesting special accommodations due to a disability will be provided during registration.
FDA has opened Docket No. FDA-2025-N-3708 and is seeking electronic or written comments on the third-party assessment. For specific instructions on submitting a comment, please refer to the Federal Register Notice.
FDA encourages respondents to provide the specific rationale and basis for their comments, including any available supporting data and information. Respondents need not address all topics of the assessment.
The Regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of December 30, 2025. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date.
Please note that late, untimely filed comments will not be considered.