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FDA to Host First Annual Animal Drug User Fee Educational Conference

  • 1.  FDA to Host First Annual Animal Drug User Fee Educational Conference

    Posted 06-17-2024 02:59 PM

    The Food and Drug Administration (FDA) has announced the first in a series of five public meetings to provide educational sessions for stakeholders who are interested in the new animal drug approval process, as 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 most recently reauthorized in 2023. As per the FDA, "ADUFA authorizes the FDA to collect fees for certain new animal drug applications, products, establishments, and sponsors."

    The first educational conference will be held on July 17, 2024, from 9 a.m. to 5 p.m. Eastern Time, with in-person and virtual participation options, and will include the following topics:

    • 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.

    More information, including registration deadlines, is available on the meeting webpage.

    Kris Johansen
    Associate Director of External Relations
    National Institute of Antimicrobial Resistance Research & Education