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An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
Why Should You Attend:
Stem cells intended for therapeutic purposes in humans are regulated as biologics under FDA’s April 2006 regulations governing the use of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) in humans. These regulations define HCT/Ps as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.”
Among other things, the regulations include provisions governing registration and listing requirements for establishments that manufacture and process HCT/Ps; provisions discussing donor eligibility; recommended current good tissue practices covering all stages of production, including harvesting, processing, manufacture, storage, labeling, packaging, and distribution; and other requirements intended to prevent the introduction, transmission, and spread of communicable diseases in humans.
An HCT/P is not automatically treated as a drug product by FDA. Instead, a drug v. non-drug distinction is made between HCT/Ps on the basis of an applied “minimal manipulation” standard and other identifiable criteria. Thus, depending on the amount of manipulation involved in the production process, a product’s satisfaction of FDA’s other regulatory criteria, and consideration of a product’s ultimate intended use, HCT/Ps (including stem cell-containing products) can be regulated as simply licensed biologics or products requiring Agency review and approval as new drugs.
This presentation will provide participants with an overview of the HCT/P regulations, an understanding of the criteria that FDA uses to determine a product’s regulatory status for marketing and sale; and a discussion of some of the risks associated with commercializing an HCT/P such as a stem cell-based product today.
- Understand the criteria that FDA uses to determine a product’s regulatory status (i.e., a biologic, drug or medical device).
- Become familiar with the various regulatory options for commercializing a stem cell-based product.
- Recognize the potential regulatory risks associated with marketing and selling an HCT/P such as a stem cell-based product.
- Exposure to FDA’s regulation of veterinary stem cell therapy.
Areas Covered in the Seminar:
- FDA’s legal authority over HCT/Ps including stem cell-based products.
- FDA’s regulation of HCT/Ps including stem cell-based products.
- The criteria FDA uses for determining an HCT/P’s regulatory status.
- The various options for commercializing HCT/Ps including stem cell-based products.
- FDA’s recent enforcement action against firms promoting stem cell-based therapies for human use.
- An introduction to veterinary stem cell therapy.
Who Will Benefit:
- Individuals who work in the Regulatory Affairs departments of pharmaceutical, biotech & biologics companies
- Quality Assurance
- In-house counsel, lawyers who work for or represent pharmaceutical and biotech companies and other legal staffers interested in the development and commercialization of HCT/Ps such as stem cell-based products
- Financial analysts specializing in and investors watching the pharmaceutical, life sciences and biotech industries
- Policy makers responsible for creating laws governing the use of stem cells
Karl M. Nobert, is an accomplished attorney with expertise in the U.S. Food and Drug Administration’s regulation of prescription and over-the-counter drug products, food, biologics, medical devices and veterinary products. Mr. Nobert possesses a considerable understanding of and experience dealing with the FDA’s regulation of human and veterinary regenerative medicine including the marketing and sale of stem cell-based products intended for human use. He frequently presents and has published on the subject, and currently services as Legal Advisor to the International Veterinary Regenerative Medicine Society”.
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Karl M. Nobert
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