Two-Day Online Veterinary Drug Approval Process and FDA Regulatory Oversight Seminar: December 2-3, 2021

DUBLIN, November 08, 2021– (BUSINESS WIRE) – “The Veterinary Drug Approval Process and FDA Regulatory Oversight Training” has been added to ResearchAndMarkets.com offer.

This two-day interactive online seminar will allow attendees to understand the FDA’s veterinary drug approval process in 2021.

The Center for Veterinary Medicine (CVM) of the United States Food and Drug Administration is responsible for approving veterinary drugs for use in companion animals, food-producing animals, and other animal species.

This seminar will cover the process of obtaining federal government approval for the marketing of new pharmaceutical products for animals that fall under the jurisdiction of the FDA, and will also briefly cover 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 United States Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.

The group size is small, usually between 8 and 10 people, with plenty of opportunities to ask questions and discuss any issues or challenges faced by participants.

Learning objectives:

The main objectives of the seminar will include learning:

  • How the United States Food and Drug Administration (FDA) regulates pharmaceuticals for animals.

  • How the FDA’s Center for Veterinary Medicine is organized.

  • The process by which veterinary pharmaceuticals are reviewed and approved.

  • How to open an INAD (Investigational New Animal Drug) file.

  • The various FDA user fees, available fee waivers, and how to request a fee waiver.

  • The different technical sections included in a New Animal Drug Application (NADA).

  • What information is needed to justify the characterization of the product, the safety and efficacy of the target animals.

  • An overview of the FDA rules governing chemistry, manufacturing and controls (CMC).

  • The various elements of an animal field study to support product approval.

  • How pet foods, veterinary devices, over-the-counter pharmaceuticals, and nutritional supplements are regulated in the United States

Main topics covered:

DAY 01

Introduction to the veterinary drug approval process

  • Definitions

  • INAD / NADA technical sections

  • Some differences between the approval process for drugs for humans and animals

  • Organization and Jurisdiction of the FDA

  • Relevant FDA Centers for Animal Health

  • Introduction to federal regulations (FD&CA, AMDUCA, ADAA, FDAMA)

  • FDA guidance documents and other online resources

  • Discovery / Acquisition – Concerns about preliminary patent protection

  • INAD / NADA progressive review

  • Open an INAD file

  • Submit the first information

  • Step-by-step review of technical sections

  • Meetings with the CVM

  • Brief description of cGxP (GMP, GLP, GCP)

Develop the NADA technical sections

  • Chemistry, manufacturing, controls (CMC)

  • Efficiency

  • The 7 major phases of clinical studies in the field

DAY 02

Develop the NADA technical sections

  • Target Animal Safety (TAS)

  • Human food security

  • Environmental impact

  • Labeling

  • Summary of Freedom of Information (FOI)

  • All other information (AOI)

Overview of Generic Animal Drugs (JINAD)

Minor Limited Use Species (UMM)

Designation

Indexing

Marketing exclusivity and exclusive marketing rights

Fees for the use of medicines for animals and related exemptions

Animal feed, over-the-counter drugs, supplements, medical devices

USDA and EPA

Non-approval considerations

For more information on this training, visit https://www.researchandmarkets.com/r/ypkdf3

See the source version on businesswire.com: https://www.businesswire.com/news/home/20211108005526/en/

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