On Nov. 2, 2026, the U.S. Food and Drug Administration (FDA) published guidance recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy (CGT) product. The FDA is issuing this guidance to assist you (manufacturers, applicants, and other stakeholders) in developing approaches for assuring the potency of CGT products.

A potency assurance strategy is a multifaceted and flexible approach that reduces risks to the potency of a product through manufacturing process design, manufacturing process control, material control, in-process testing, and potency lot release assays. The goal of a potency assurance strategy is to ensure that every lot of a product released will have the specific ability or capacity to achieve the intended therapeutic effect.

This final guidance supersedes the document entitled “Guidance for Industry: Potency Tests for Cellular and Gene Therapy Products,” dated January 2011.