FDA Announces Third Annual Animal Drug User Fee Educational Conference
June 2, 2026
Today, the U.S. Food and Drug Administration is announcing the Third Annual Animal Drug User Fee Educational Conference, which will take place on July 7, 2026. This conference is the third in a series of five annual conferences that provide educational sessions for stakeholders interested in the new animal drug approval process.
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. The Animal Drug User Fee Act Reauthorization – Performance Goals and Procedures – Fiscal Years 2024-2028 sets forth the agency's performance goals for the period covered by ADUFA V. Among other goals, the agency has committed 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 eight hours for an educational conference intended for the animal drug industry; however, the meeting is open to the public.
The next educational conference will be held on July 7, 2026, from 9:00 a.m. to 1:00 p.m. Eastern Time. Attendees can join in-person or virtually. The in-person conference will be held at the Harvey W. Wiley Federal Building, 5001 Campus Drive, College Park, MD 20740.
For more information about the conference, including a link to registration, please see: CVM Public Meeting: Third Annual Animal Drug User Fee Educational Conference. Early registration is recommended for people who wish to attend the conference in person. The registration deadline for in-person attendance is June 25, 2026. People interested in attending the conference virtually will be able to register until the start time of the meeting. Registrants will receive a confirmation email with the webcast link when the FDA receives their registration.
This year’s conference will include presentations covering 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 will also contain a Q&A session during which the FDA will address specific questions from the in-person and virtual audience, as time permits. Future educational conferences will include topics based on questions and comments received during this meeting and submitted to the docket.
All stakeholders are welcome to submit comments to the docket to request topics for inclusion in future educational conferences. The FDA is accepting public comments at any time for this series of educational conferences; however, the agency requests that you submit either electronic or written comments within 90 days of each annual educational conference to ensure that the agency considers your comment on a topic discussed at that conference.