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First Annual Animal Drug User Fee Educational Conference

The U.S. Food and Drug Administration is announcing the first of 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 four 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.

The first educational conference will be held on July 17, 2024, 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, please see the meeting webpage.

This initial conference will provide a high-level overview of the animal drug approval process; communication pathways with the FDA’s Center for Veterinary Medicine; best practices in the approval process; target animal safety technical section overview; effectiveness technical section overview; chemistry, manufacturing and controls technical section overview; human food safety technical section overview; environmental impact technical section overview; and minor technical sections overview.

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 conferences will take a more in-depth approach to these and other topics based on questions and comments received during this meeting, as well as questions and comments 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. Registrants will receive confirmation when their registration has been received and they will be provided the webcast link. Persons interested in attending this conference virtually may register until the start time of the meeting. Persons interested in attending this conference in-person are encouraged to register online at https://fda.zoomgov.com/webinar/register/WN_cSFEyfDpQK6RuGrwPznG9AExternal Link Disclaimer no later than July 10, 2024. 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 see the meeting webpage.

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