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FDA Publishes Draft Guidance on Human Cellular and Gene Therapy Products

July 20, 2023


FDA published a draft guidance document on July 13, 2023 outlining recommendations for manufacturing of products related to human cellular therapy or gene therapy (CGT). Recommendations included product compatibility and manufacturing changes regarding investigational and licensed CGT products. The draft guidance document reflected FDA’s current view on “management and reporting of manufacturing changes for CGT products based on a lifecycle approach, and comparability studies to assess the effect of manufacturing changes on product quality.”

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