Animal Drug Approval Process

Two-Day Seminars

Overview of Clinical and Regulatory Development for FDA Veterinary Drug Approval

Next Seminar Date: TBD

Please contact us by email if you would like to suggest a date or location for the next seminar..

Course Description

Has your laboratory or company developed a drug that has huge potential for treating a disease in companion animals, and now you want to know what it takes to get approval from the FDA to market the drug in the USA?

Is it clear whether your potential product is a drug regulated by the FDA, an animal biologic regulated by the USDA, or something else?

If it is a drug that needs FDA approval, what are the steps that you should take to seek FDA approval?

This two-day seminar is designed to provide answers to these questions and to give you a comprehensive overview of the veterinary drug approval process and point you to some resources available to assist you on your journey to regulatory approval.

Typical group size is 8-12 people, which allows for plenty of interaction and discussions. Participants are encouraged to ask questions at any time during the presentations.

Who Will Benefit

This course is designed for people tasked with developing a pharmaceutical or animal health company’s product portfolio and responsible for overseeing a company’s clincal development and regulatory strategies. This includes individuals responsible for overseeing regulatory affairs, developing veterinary drug products, evaluating new technologies or applications, and those tasked with ensuring corporate compliance.

Learning Objectives

Understand how the U.S. Food and Drug Administration (FDA) regulates veterinary drug products.
Understand how FDA’s Center for Veterinary Medicine (CVM) is organized.
Learn the difference between animal drugs regulated by CVM and animal biologics regulated by the U.S. Department of Agriculture (USDA).
Discuss the process by which veterinary drug products are reviewed and approved by CVM.
Learn how to open an INAD File and request fee waivers.
Obtain a working knowledge of various sections included within a New Animal Drug Application (NADA).
Develop an understanding of what data is needed to support product characterization, target safety and effectiveness.
Gain general understanding of FDA’s rules governing chemistry, manufacturing and controls (CMC).
Understand the various components of an animal field study to support product approval.
Discuss the difference between FDA’s various user fees and fee waivers.
Identify the elements of an FDA compliant label.
Get a brief overview on how animal feed, veterinary devices, OTC drug products and nutritional supplements are regulated in the USA.

Hughes Veterinary Consulting (HVC)