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Product safetyFDAUnited StatesImports

Potency Assurance for Cellular and Gene Therapy Products; Guidance for Industry; Availability

3 November 2026

In plain English

FDA issued final guidance, Potency Assurance for Cellular and Gene Therapy Products, giving recommendations for assuring potency of CGT products throughout the product lifecycle.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
3 November 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance titled "Potency Assurance for Cellular and Gene Therapy Products." The guidance document provides recommendations to help assure the potency of human cellular therapy or gene therapy (CGT) products at all stages of the product lifecycle. FDA is recommending a comprehensive approach to potency assurance of CGT products that is grounded in quality risk management. For investigational products, we
The full text is at the source

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