FDA Potency Assurance Guidance: What It Asks of Cell and Gene Therapy Makers

The FDA potency assurance guidance for cellular and gene therapy (CGT) products is now final. The Center for Biologics Evaluation and Research (CBER) dated it November 2026. It replaces the January 2011 version, “Potency Tests for Cellular and Gene Therapy Products,” and describes how sponsors can assure potency from early investigational stages through lot release of licensed products.

Scope of the FDA potency assurance guidance

The guidance covers CGT products regulated as biological products under section 351 of the Public Health Service Act. It does not apply to vaccines for infectious disease indications, bacteriophage products, live biotherapeutic products, fecal microbiota for transplantation products or allergenic products.