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Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations Draft Guidance for Industry September 2025 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/innovative-designs-clinical-trials-cellular-and-gene-therapy-products-small-populations?utm_medium=email&utm_source=govdelivery Postapproval Methods to Capture Safety and Efficacy Data for Cell and Gene Therapy Products Draft Guidance for Industry September 2025 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postapproval-methods-capture-safety-and-efficacy-data-cell-and-gene-therapy-products?utm_medium=email&utm_source=govdelivery Expedited Programs for Regenerative Medicine Therapies for Serious Conditions Draft Guidance for Industry September 2025 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-regenerative-medicine-therapies-serious-conditions-0?utm_medium=email&utm_source=govdelivery