Opportunity
Federal Register #2026-22427
FDA final guidance on potency assurance for cellular and gene therapy products
Buyer
Food and Drug Administration
Posted
November 03, 2026
Identifier
2026-22427
The U.S. Food and Drug Administration has issued final guidance on potency assurance for cellular and gene therapy products. - Government buyer: U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER). - Notice type: Informational guidance, not a procurement solicitation or award. - Guidance topic: A science- and risk-based approach to assuring potency throughout the lifecycle of human cellular and gene therapy products. - Covers manufacturing process design and controls, material controls, in-process testing, and potency lot-release assays. - Addresses investigational products, products in rapid clinical development, and licensed products. - Recommends integrating potency assurance into quality systems, risk assessment, and regulatory engagement, with practical examples. - OEMs and vendors: None identified. - Products, services, quantities, and part numbers: None requested.
Description
The FDA announces the availability of final guidance on assuring the potency of human cellular and gene therapy products throughout their lifecycle. It recommends a comprehensive, science- and risk-based approach involving manufacturing process design and control, material control, in-process testing, and potency lot-release assays. The guidance discusses progressive implementation for investigational products, including products undergoing rapid clinical development, and potency-assurance requirements for licensed products. It finalizes draft guidance issued December 28, 2023.