FDA releases final guidance on potency assurance for cellular and gene therapy products
The notice, published November 3, 2026, announces the availability of the guidance with docket number FDA-2023-D-4299. It recommends a comprehensive strategy grounded in quality risk management for both investigational and licensed CGT products.
Primary source
Federal Register notice, November 3, 2026
Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability
Read the source: Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability federalregister.gov
Machine-summarized from the source above; not independently reported. How we use automation