Regulatory Dashboard | Navigating FDA’s Guidance on Potency Assurance for Cellular and Gene Therapy Products

The FDA’s Office of Therapeutic Products recently introduced a draft guidance document titled “Potency Assurance for Cellular and Gene Therapy Products .”

This guidance offers recommendations for developers of human cell and gene therapy products (referred to as CGT products) on how to establish strategies for controlling the potency of these complex products. The guidance differentiates from the previous one released in 2011 and titled “Potency Tests for Cellular and Gene Therapy Products focused exclusively on the development of potency assays. As a reflection of advancements and learnings in the CGT field, the draft guidance, once finalized, will supersede and replace the 2011 one.


Written by Lara Stevanato, PhD, Ergomed Associate Director of Regulatory Affairs, Biologics and ATMPs

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