Conference | Mixed
Event Title
CVM Public Meeting: Third Annual Animal Drug User Fee Educational Conference
July 7, 2026
- Date:
- July 7, 2026
- Time:
- 9:00 a.m. - 1:00 p.m. ET
- Organized By:
-
Organizer
On This Page:
Background
On Tuesday, July 7, 2026, the FDA’s Center for Veterinary Medicine hosted the Third Annual Animal Drug User Fee Educational Conference. The conference provided educational sessions for stakeholders who are interested in the new animal drug approval process. The series of five annual educational conferences hosted by the FDA are described in the Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028.
The Animal Drug User Fee Act (ADUFA) was originally signed into law in 2003 and was subsequently reauthorized by Congress in 2008, 2013, 2018, and 2023. ADUFA authorizes the FDA to collect fees for certain new animal drug applications, products, establishments, and sponsors. Resources generated under ADUFA supplement the agency's funding to enhance the performance of the drug review process. The animal drug review process ensures that new animal drug products are safe and effective for animals, and that food derived from treated animals will be safe for consumption. The FDA considers the timely review of the safety and effectiveness of new animal drug applications to be central to the agency’s mission to protect and promote human and animal health.
The Animal Drug User Fee Amendments of 2023 (ADUFA V), the most recent reauthorization of ADUFA, authorizes the FDA to collect user fees through fiscal year 2028. Animal Drug User Fee Act Reauthorization Performance Goals and Procedures Fiscal Years 2024 Through 2028 sets forth the agency's performance goals for the period covered by ADUFA V. Among other goals, the document commits the agency to hosting triannual meetings (three meetings per calendar year) with Animal Health Institute members. Each year, during one of these meetings, the FDA will commit up to 8 hours for an educational conference intended for the animal drug industry.
Public Meeting Information
The third annual educational conference was held in-person and virtually. The in-person conference was held at the Harvey W. Wiley Federal Building, 5001 Campus Drive, College Park, MD 20740.
This conference provided presentations on the following areas:
- Available regulatory pathways
- Conditional approval and indexing for Minor Use/Minor Species
- Expanded conditional approval and reasonable expectation of effectiveness
- Real world example of regulatory flexibility during a public health emergency
- Animal biotechnology products and the Veterinary Innovation Program
- Protocol quality and best practices
The conference contained a Q&A session during which the FDA addressed specific questions from the in-person and virtual audience. Future educational conferences will include topics based on questions and comments received during this meeting and submitted to the docket.
Submitting Written or Electronic Comments
The FDA has opened a docket and is accepting electronic or written comments. You may submit comments at any time for this series of educational conferences; however, we request that you submit comments within 90 days of each annual educational conference to ensure that the agency considers your comment on a topic discussed at that conference.
To electronically submit comments to the docket, visit docket FDA-2024-N-2602 on www.regulations.gov.
To submit a comment to the docket by mail or to submit a comment with confidential information that you do not wish to be made publicly available, follow the instructions in the Federal Register Notice.
All submissions received must include the Docket No. FDA-2024-N-2602 for “Animal Drug User Fee Educational Conference.” All comments received will be placed in the docket.
Event Materials
Questions?
For questions, please contact adufa_v_edu_conference@fda.hhs.gov.