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  5. CVM Public Meeting: ADUFA Third-Party Assessment Report - 10/30/2025
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Virtual | Virtual

Event Title
CVM Public Meeting: ADUFA Third-Party Assessment Report
October 30, 2025

Date:
October 30, 2025
Time:
10:00 a.m. - 12:00 p.m. ET
Organized By:
Organizer

On This Page:

Background

On Thursday, October 30, 2025, the FDA’s Center for Veterinary Medicine (CVM) will host a virtual public meeting to provide an overview of a third-party assessment 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. 

The assessment evaluated the effectiveness of the ADUFA program, 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 covered CY 2024 and was completed in December 2024.

Virtual Public Meeting Information

This public meeting is virtual only. The virtual meeting will be available via a webcast link that registrants will receive after completing registration. Please see the “Registration” section below for more details.

Registration

Persons interested in attending this virtual public meeting must register online at https://events.gcc.teams.microsoft.com/event/0c499308-1f4e-49ef-8c23-a3d3b0712963@7d2fdb41-339c-4257-87f2-a665730b31fc. Please provide complete contact information for each attendee, including name, title, affiliation, address, email, and telephone number. 

Registration is free but limited to 1000 participants. Persons interested in attending this virtual public meeting must register by 11:59 pm ET on October 29, 2025. Registrants will receive confirmation when they have been accepted.  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.

Submitting Electronic or Written Comments

The FDA is seeking input, via written comments to Docket No. FDA 2025-N-3708, on any and all aspects of the third-party assessment.  The 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. 

Please note that late, untimely filed comments will not be considered.  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.

To submit comments to the docket by mail, follow the instructions in the Federal Register notice.

All submissions received must include the Docket No. FDA-2025-N-3708 for “ADUFA V Third-Party Assessment Report.” All comments received will be placed in the docket.

Do not electronically submit any information you consider Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. 

 

Event Materials

Forthcoming

Event Materials

Title File Type/Size
adufa_v_third-party_assessment_report_final.pdf pdf (3.48 MB)
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