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FDA Draft Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products


Office of Communication, Outreach and Development (OCOD), 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002, or by calling 1-800-835-4709 or 240-402-8010, or email, or from the Internet at

Document Type:
Draft Guidance
The scope of this guidance is limited to ensuring the effectiveness of CGT products regulated as biological products under Section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262). This guidance provides recommendations for ensuring the effectiveness of CGT products at all stages of their product life cycle. For investigational products, it explains how to implement a step-by-step strategy to ensure efficacy during product development. It also provides specific considerations for ensuring the efficacy of products undergoing rapid clinical development.

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