An Introduction to FDAs Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products ( (Biotech)

Venue: Online Event

Location: Palo Alto, California, United States

Event Date/Time: Mar 22, 2011 End Date/Time: Mar 22, 2011
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Description

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.

Learning Objectives:

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 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.

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Venue

Online Event
2600 E. Bayshore Road
Palo Alto
California
United States
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