FDA Regulations for Cellular Therapy Products: What Applies Now
Program Code: 9109-QE-CT
Saturday, October 24, 2009
10:30 AM to 12:00 PM (ET)

MODERATOR
Janice Davis-Sproul, MAS, MT(ASCP)SBB, Johns Hopkins Medicine

SPEAKERS
Ellen F. Lazarus, MD, CAPT, USPHS, Food and Drug Adminstration

DESCRIPTION
The FDA uses a risk-based approach for the regulation of human cells and tissues. This means that the regulations can be applied to a wide variety of products and that the type of regulation is commensurate with the risk posed by the product. This approach has yielded two categories of cell and tissue-based products, often referred to as 351 and 361 products.

This session will use lectures and case studies to review and interpret FDA regulations for Cellular and Tissue-Based Products. The focus will be on understanding the framework of product classification in order to determine which products require an IND/IDE and which do not.