Regulation of Biological Products Based on Sound Science, Law and Public Health Impact

10/29/02


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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?

Author: Becky Devine