Considerations for a Revised Risk-Based HCT/P Framework: Presentations

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Back to: Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development

Lesson Description

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) hosted a virtual scientific public workshop on February 25, 2025, titled “Cell Therapies and Tissue-based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development.” The purpose of the workshop was to identify and discuss the current state of the science, development, and regulation for cellular therapies and tissue-based products.

In this session, presentations on “Considerations for a Revised Risk-Based HCT/P Framework”:

“Considerations for a Revised Risk-Based HCT/P Framework”

• Julie Tierney, JD, Deputy Center Director, CBER, FDA

“Considerations for a Revised Risk-Based HCT/P Framework”

• Melissa A. Greenwald, MD, FAST, Chief Medical Officer, American Association of Tissue Banks