DUBLIN – (BUSINESS WIRE) – “The Veterinary Drug Approval Process and FDA Regulatory Oversight” training has been added ResearchAndMarkets.com offer.
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for approving veterinary drugs for pets, food-producing animals, and other species. This seminar covers the process of obtaining federal government approval to commercialize new veterinary drugs that are under the jurisdiction of the FDA and, briefly, animal products that are regulated by other federal agencies. For example, animal vaccines, animal disease diagnostics, and some biological veterinary drugs are regulated by the U.S. Department of Agriculture, and some flea and tick control products are regulated by the Environmental Protection Agency.
This three-day interactive seminar provides attendees with an understanding of the FDA’s veterinary drug approval process. The group size is small, usually between 8 and 20 people, with plenty of opportunities to ask questions and discuss problems or challenges that the participants have experienced.
The main objectives of the seminar include learning:
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How the US Food and Drug Administration (FDA) regulates veterinary drugs.
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How the FDA’s Center for Veterinary Medicine is organized.
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The process by which veterinary medicinal products are tested and approved.
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How to open an Investigational New Animal Drug (INAD) file.
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The various FDA user fees, what fee waivers are available, and how to apply for a fee waiver.
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The various technical sections contained in a New Animal Drug Application (NADA).
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What information is required to support product characterization, safety, and efficacy of target animals?
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An overview of the FDA’s Chemistry, Manufacturing, and Controls (CMC) regulations.
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The various components of a tier field study to support product approval.
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How Pet Food, Veterinary Medicines, OTC Drugs, and Diet Supplements are Regulated in the United States
Key topics covered:
day 1
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Introduction to the approval process for veterinary medicinal products
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Definitions
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INAD / NADA technical sections
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Some differences between the approval process for human and veterinary medicinal products
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FDA organization and jurisdiction
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FDA centers relevant to animal health
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Introduction to Federal Regulations (FD&CA, AMDUCA, ADAA, FDAMA)
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FDA guidelines and other online resources
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Discovery / Acquisition – Preliminary Patent Protection Concerns
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INAD / NADA phase review
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Open an INAD file
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Submit early information
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Phased review of the technical sections
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Meeting with CVM
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Brief description of cGxP (GMP, GLP, GCP)
day 2
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Development of the NADA Technical Sections
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Chemistry, Manufacturing, Controls (CMC)
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effectiveness
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The 7 main phases of clinical field studies
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Target Animal Safety (TAS)
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Food safety for humans
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Ecological damage
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labeling
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Summary of Freedom of Information (FOI)
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All other information (AOI)
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Overview of Generic Veterinary Medicinal Products (JINAD)
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Submissions – ANADA Sections
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cc
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Bioequivalence (safety & effectiveness)
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Food safety for humans
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labeling
Day 3
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Minor Use Minor Species (MUMS)
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designation
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indexing
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Marketing exclusivity and exclusive marketing rights
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Veterinary drug usage fees and related exemptions
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Animal feed, OTC drugs, food supplements, medical devices
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USDA & EPA regulated animal health products
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Non-regulatory considerations
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Use of extra-label drugs
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Compounding
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Non-compliance and Enforcement
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Pharmacovigilance
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Post-Approval Submissions for CMC Changes
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Overview of the typical steps involved in the development of veterinary medicinal products
Please visit https://www.researchandmarkets.com/r/8flj8r for more information about this training
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