Veterinary Drug Approval Process and FDA Regulatory Guidance (ONLINE EVENT: July 25-26, 2024)

This two-day interactive seminar online will provide attendees with an understanding of the FDA’s veterinary drug approval process in 2024. The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for the approval of veterinary drug products intended for family pets, food-producing animals, and other animal species. This seminar will cover the process for obtaining federal government approval for marketing new animal drug products that are under the jurisdiction of the FDA, and also briefly covers animal products that are regulated by other federal agencies. For example, animal vaccines, animal disease diagnostic devices and some animal biologics are regulated by the U.S. Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.

The group size is small, generally between 8 and 10 people, with plenty of opportunities to ask questions and discuss issues or challenges that the attendees have experienced.

Course Highlights :

4 New Guidance Documents published by the FDA will also be discussed:

• #265 Use of Data from Foreign Investigational Studies to Support Effectiveness of New Animal Drugs
• #266 Use of Real-World Data and Real-World Evidence to Support Effectiveness of New Animal Drugs
• #267Biomarkers and Surrogate Endpoints in Clinical Studies to Support Effectiveness of New Animal Drugs
• #268 Adaptive and Other Innovative Designs for Effectiveness Studies of New Animal Drugs

Learning Objectives:

Key goals of the seminar will include learning:

• How the U.S. Food and Drug Administration (FDA) regulates animal drug products.
• How FDA’s Center for Veterinary Medicine is organized.
• The process by which veterinary drug products are reviewed and approved.
• How to open an Investigational New Animal Drug (INAD) File.
• The FDA’s various user fees, what fee waivers are available, and how to request a fee waiver.
• The various technical sections included in a New Animal Drug Application (NADA).
• What information is needed to substantiate product characterization, target animal safety and effectiveness.
• An overview of FDA’s rules governing chemistry, manufacturing and controls (CMC).
• The various components of an animal field study to support product approval.
• How animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the U.S.

RAPS - This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.