by Fajar Dumadi, BSc
Regulatory Program Specialist
ISCT Head Office
This draft guidance provides recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. This draft guidance document, when finalized, will supersede the document entitled “Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products” dated January 2011 (January 2011 guidance). When finalized, this guidance will describe the FDA’s recommendations for potency assays for CGT products and for a comprehensive approach to potency assurance that is grounded in quality risk management.
ISCT comments were submitted on 27 March 2024.
Agency
US Food & Drug Administration
Timeframe:
Public comments period open from 27 December 2023 to 27 March 2024
Contributing Committee(s):
Global Regulatory Task Force
Global Industry Committee
North America Legal and Regulatory Affairs Committee
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