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# Cell/Gene Product Potency Assurance
- URL: https://www.fdaweb.com/cell-gene-product-potency-assurance/
- Published: 2024-01-02T12:00:00.000Z
- Updated: 2026-09-14T14:19:14.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156027

FDA has published a draft guidance, *Potency Assurance for Cellular and Gene Therapy Products*, with recommendations for developing a science- and risk-based strategy to help assure the potency of a human cellular therapy or gene therapy product. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/potency-assurance-cellular-and-gene-therapy-products?ref=fdaweb.com) says a potency assurance strategy is “a multifaceted 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.”

FDA says that when it is finalized, the draft will supersede a 1/2011 guidance.

The draft contains an Introduction, Background, Regulatory Framework, Developing a Potency Assurance Strategy, and Potency Assays and Acceptance Criteria.