This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlight the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S.
FDA’s Center for Veterinary Medicine (“CVM”) asserts primary and exclusive regulatory jurisdiction over veterinary regenerative products and their future commercialization in the U.S. Under CVM’s proposed regulatory approach, a veterinary regenerative product exceeding a hypothetical veterinary equivalent standard will be treated as a drug requiring FDA review and approval prior to marketing and sale.
This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlights the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S. It will provide an introduction to veterinary stem cell therapy, an overview of the veterinary drug approval product, a summary of FDA’s potential reliance on human cellular regulations to regulate such products, and recommendations for industry on strategies for mitigating FDA enforcement risks.
Why Should You Attend:
The rapid development of cell-based and related biological therapies for use in veterinary medicine has provided exciting new options for the safe and effective treatment of common veterinary diseases and conditions such as osteoarthritis, tendon strain injuries, suspensory desmitis, congestive heart failure and other commonly diagnosed diseases and injuries.FDA’s Center for Veterinary Medicine (“CVM”) asserts primary and exclusive regulatory jurisdiction over veterinary regenerative products and their future commercialization in the U.S. Under CVM’s proposed regulatory approach, a veterinary regenerative product exceeding a hypothetical veterinary equivalent standard will be treated as a drug requiring FDA review and approval prior to marketing and sale.
This webinar will provide an introduction to FDA’s regulation of veterinary regenerative medicine and highlights the regulatory requirements that a biotech company needs to satisfy to commercialize a stem cell or other complex biotech product for animal use in the U.S. It will provide an introduction to veterinary stem cell therapy, an overview of the veterinary drug approval product, a summary of FDA’s potential reliance on human cellular regulations to regulate such products, and recommendations for industry on strategies for mitigating FDA enforcement risks.
Learning Objectives:
- Provide an introduction to the veterinary regenerative medicine and stem cell therapy market.
- Gain a basic understanding of FDA's regulatory oversight of cellular and other complex biotech products for use in animals.
- Provide attendees with an overview of how stem cells products are currently regulated by FDA.
- Describe the criteria used by FDA for distinguishing between a stem cell product regulated as a drug and one that is not, and how a similar standard may be applied to veterinary stem cell products.
- Learn how FDA is currently regulating drug products for veterinary use.
- Highlight known FDA regulatory activity in the market.
- Discuss what FDA looks for when is reviews labeling and identify some of the biggest mistakes made when it comes to marketing and advertising.
- Provide recommendations for mitigating the risk of FDA enforcement action.
Areas Covered in the Seminar:
- Who regulates veterinary cellular and tissue products; and biotherapeutic products intended for commercialization.
- FDA's regulation of veterinary regenerative medicine including stem cells and other biotherapeutics.
- FDA's currently regulation of human cellular and tissue products; and how those same regulatory policies may be applied to veterinary products.
- Discussion of the new animal drug approval process.
- The potential for a drug/non-drug distinction to be made between products based on the amount of processing applied to the product.
- What are the requirements for labeling, marketing and advertising such a product.
- Strategies for mitigating FDA enforcement risks.
Who Will Benefit:
- Regulatory Affairs Professionals
- Professors
- Managers
- Consultants
- Scientists
- Research Analysts
- State Policy Officials
- Insurers focusing on Representations & Warranties Insurance
- Investment Analysts
- Venture Capitalists
- Stem Cell Companies, Biotech, Animal Drug Companies, Pharmaceutical Companies, Veterinarians, Veterinary Hospitals and Clinics
- Financial analysts and investors watching the pharmaceutical, life sciences and biotech industries
Course Provider
Karl M. Nobert,
