# 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 It finalizes draft guidance issued December 28, 2023.

[View original listing](https://www.federalregister.gov/documents/2026/11/03/2026-22427/potency-assurance-for-cellular-and-gene-therapy-products-guidance-for-industry-availability)