Veterinary Drug Approval Process and FDA Regulatory Guidance

Veterinary Drug Approval Course Description

Presented by Karl M. Nobert Founder of ReCellerate Inc., a veterinary pharmaceutical company 30+yrs exp.

This two-day interactive seminar online will provide attendees with an understanding of 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 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

Training Agenda

DAY 01

Introduction to the Veterinary Drug Approval Process

• Definitions
• INAD/NADA technical sections
• Some differences between human and animal drug approval process
• FDA organization and jurisdiction
• FDA Centers relevant to Animal Health
• Introduction to Federal Regulations (FD&CA, AMDUCA, ADAA, FDAMA)
• FDA Guidance documents and other online resources
• Discovery/Acquisition - Preliminary Patent Protection Concerns
• INAD/NADA Phased Review
• Open an INAD File
• Submit Early Information
• Phased Review of Technical Sections
• Meetings with CVM
• Brief description of cGxP (GMP, GLP, GCP)

Developing the NADA Technical Sections

• Chemistry, Manufacturing, Controls (CMC)
• Effectiveness
• The 7 Major Phases of Clinical Field Studies

DAY 02

Developing the NADA Technical Sections (continued)

• Target Animal Safety (TAS)
• Human Food Safety
• Environmental Impact
• Labeling
• Freedom of Information (FOI) Summary
• All Other Information (AOI)

Overview of Generic Animal Drugs (JINAD)

• Submissions - ANADA sections
• CMC
• Bioequivalence (Safety & Efficacy)
• Human Food Safety
• Labeling

Minor Use Minor Species (MUMS)

• Designation
• Indexing

Marketing Exclusivity & Exclusive Marketing Rights

Animal Drug User Fees and related waivers

Animal Feed, OTC Drugs, Supplements, Medical Devices

USDA & EPA

Non-Approval-Related Considerations

• Extra-Label Drug Use
• Compounding
• Noncompliance and Enforcement
• Pharmacovigilance
• Post-approval submissions for CMC changes

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.

Who will Benefit

This course is designed primarily for people tasked with developing new animal drugs for an animal health company or a human pharmaceutical company. This includes individuals responsible for overseeing regulatory affairs, developing veterinary drug products, or evaluating new technologies or applications. Among others, this includes:

• Personnel new to the Animal Health Industry
• CRO professionals
• Entrepreneurs looking to add value to their products
• Regulatory professionals
• Compliance professionals
• U.S. Agents of Foreign Corporations
• Legal Professionals
• Financial Advisors and Institutional Investors