Veterinary Drug Approval Process and FDA's Regulatory Oversight

Why Should You Attend:

CVM (Center for Veterinary Medicine) plays a substantial role in ensuring human food safety by establishing the maximum levels of drug residues permitted in meat, milk, and eggs; by minimizing the emergence and spread of antibiotic-resistant bacteria that could infect humans through animal-derived foods, and by regulating substances in animal feed that could impact the human food supply such as the agent that causes “mad cow” disease.

FDA does not regulate all veterinary products. Instead, federal regulatory jurisdiction is shared with other federal agencies such as USDA’s Animal and Plant Health Inspection Service (APHIS) (i.e., licensed biologics); and the Environmental Protection Agency (i.e., flea and tick collars).

This webinar will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also offer them a broad understanding of various sections included within an NADA, rules governing Chemistry, Manufacturing and Controls (CMC), and the elements of an FDA compliant label.

Learning Objectives:

• Understand how the U.S. FDA regulates veterinary drug product
• Be able to confidently discuss the process by which veterinary drug products are reviewed and approved
• Learn how to open an INAD file and request fee waivers
• Obtain a working knowledge of various sections included within an NADA
• Develop a basic understanding of what is required to substantiate product characterization, target safety and effectiveness
• Become familiar with the rules governing CMC
• Understand the key components of an appropriate animal field study needed to support new animal drug approval
• Be able to identify the elements of an FDA compliant label
• Be able to explain how jurisdiction is split between various federal agencies in certain cases

Areas Covered in the Webinar:

• Introduction to the FDA, CVM, and the FDCA
• Overview of Veterinary Drug Approval Process
• Approval Process: Safety, Effectiveness, and Human Food Safety
• Animal Drug User Fees and Related Fee Waivers
• Shared Jurisdiction with other Federal Agencies
• Labels, Labeling, Marketing and Advertising

Who Will Benefit:

This course is designed for people tasked with developing and maintaining an animal health company’s product portfolio; and responsible for overseeing a company’s regulatory strategies. This includes individuals responsible for overseeing regulatory affairs, developing strategies for obtaining veterinary drug product approvals and those tasked with ensuring corporate compliance. Among others, this includes:

• Senior quality managers
• Quality professionals
• Regulatory professionals
• Compliance professionals
• Labelers and private labelers
• Contract manufacturers
• Importers and custom agents
• U.S. agents of foreign corporations
• Legal professionals
• Financial advisors and institutional investors
• Consultants, inspectors and cGMP experts

Karl M. Nobert
President, ReCellerate, Inc.

Karl Nobert, is a Food & Drug Regulatory Attorney and a Principal with The Nobert Group which focuses on FDA and USDA legal issues. He provides regulatory advice and counseling to both domestic and international food and feed companies. Among others, his clients include ingredient manufacturers, formulators, labelers, distributors and exporters of various animal health products. He also has considerable experience related to the regulation of veterinary biologics including veterinary cellular and genetic therapies.

Topic Background:

The U.S. Food and Drug Administration’s Center for Veterinary Medicine or CVM is responsible for the approval of veterinary drug products intended for both family pets and food-producing animals. Under the Federal Food, Drug, and Cosmetic Act, before a new animal drug product may be marketed and sold in the United States, it must first obtain FDA pre-market approval. This requirement is intended to ensure that all veterinary drug products are both safe and effective for their intended uses.

Before FDA will approve a new veterinary drug product, a sponsor must substantiate the safety and effectiveness of the product for use under the conditions prescribed on the product label. This is intended to protect both the nation’s animal and human populations from the detrimental impact of unsafe and dangerous drug products.

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