• KC Animal Health
    June 17 | 8:30AM
    Animal Health Regulatory 101
    Regulatory affairs.gif

    June 17 &18, 2020 at Kansas State University Olathe campus

    Animal Health Regulatory 101 An Introductory Course on the Regulatory Aspects of Animal Drug and Vaccine Development

    Kansas State University Olathe campus
    22201 W. Innovation Drive, Olathe, KS

    June 17 | 8:30 a.m. to 4:30 p.m.
    June 18 | 8:30 a.m. to 4:30 p.m.

    Session Summary 

    This workshop on veterinary medicine regulations will provide attendees with an understanding of veterinary drug approval processes for both FDA and USDA. Upon completing this course on veterinary medicine regulations participants will have learned:

    • The nature of jurisdiction over veterinary products between USDA and FDA
    • How to avoid common problems
    • How to open an INAD File and request fee waivers
    • The veterinary approval process across FDA and USDA
    • Various sections of a New Animal Drug Application (NADA – pioneer products) and Abbreviated NADA (ANADA – generic products)
    • A working knowledge of the major and minor technical sections included within an FDA/CVM NADA and/or ANADA
    • Strategies and plans for navigating the FDA/CVM approval process
    • How to avoid common problems
    • ADUFA and AGDUFA fee waivers, including how to obtain these waivers
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