Courtesy of NAA:

The U.S. Food and Drug Administration (FDA) is announcing the second meeting in a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process.

The annual educational conferences the FDA will host over the next three years 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, ensuring 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 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 (AHI) 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; however, the meeting is open to the public.

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About the Conference:

The next educational conference will be held on July 15, 2025, from 9 a.m. to 5 p.m. Eastern Time. Attendees can join in-person or virtually. The in-person conference will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Great Room Conference Center, Silver Spring, MD 20993–0002. For more information, click here.

The conference will provide an overview of user fees and waivers, and presentations on foreign data, real world data/evidence, what makes a high-quality submission, and adaptive study designs.

The conference will also contain Q&A sessions during which the FDA will address specific questions from the in-person and virtual audience as time allows. Future educational meetings 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 requesting topics to be included for 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 by 90 days after each annual educational conference to ensure that the agency considers your comment on a topic discussed at that conference.

Early registration is recommended for persons who wish to attend the conference in person (no later than July 8, 2025). Persons interested in attending this conference virtually may register until the start time of the meeting. You may register online at https://www.surveymonkey.com/r/ADUFAV_2025External Link Disclaimer. Registrants will receive confirmation when their registration has been received and they will be provided the Town Hall Teams link. On-site registration will be provided on the day of the meeting on a first-come, first-served basis, until the room capacity is reached. For more information about registration, please click here.