Table of Contents
FDA Science Board Office of Cellular, Tissue, and Gene Therapies (OCTGT) Kathryn C. Zoon, PhD October 25, 2002
Regulation of Biological Products Based on Sound Science, Law and Public Health Impact
Why?
Cell and Gene Therapy INDS Reviewed by CBER
Mission
Expertise
PPT Slide
PPT Slide
PPT Slide
PPT Slide
PPT Slide
Ex Vivo Transduced CD34+ Cells Expressing HSV tk
Biological – Medical Device Combination Products
General Principles
Risk based Approach to Regulation of Cells and Tissues
The New U.S. FDA “Tissue Rules”
Biosafety Testing for Cellular & Tissue-Based Products
Regulatory Concerns Common to ALL Cellular Components
Regulatory Concerns Common to ALL Cellular Components
Clinical Efficacy Trial Design
One Size does NOT! Fit ALL
What are we doing?
What are we doing? Public Discussions
What are we doing?
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Author: Becky Devine
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