FDA Wants Cell and Gene Therapies to Prove Their Potency
Published Date: 11/3/2026
Notice
Summary
The FDA just released new rules to make sure cellular and gene therapy products work as promised, from early development to final approval. Companies making these therapies need to follow clear testing steps to prove their products’ strength and safety. This helps speed up safe treatments while keeping quality high—so patients get the best care without delays or surprises.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Lot‑Release Potency Rules for Licensed CGT
If you make licensed human cellular or gene therapy (CGT) products regulated under section 351 (42 U.S.C. 262), the FDA final guidance describes requirements for potency assurance, including testing required for lot release assays. The guidance is intended to ensure every released lot has the ability to achieve the intended therapeutic effect.
Progressive Potency Strategy for Investigational Products
For investigational CGT products, the FDA describes how sponsors should progressively implement a potency assurance strategy during product development and provides extra considerations for products undergoing rapid clinical development. The guidance is aimed at guiding how potency testing and controls should be built up as the product moves through development.
More Guidance on Quality Systems and Risk
The final guidance adds advice on integrating potency assurance into existing quality systems, expanded risk‑assessment guidance, and practical examples and terminology refinements. These changes are intended to help sponsors apply quality risk management approaches to potency assurance.
Guidance Is Non‑Binding; Alternatives Allowed
The FDA states the guidance reflects its current thinking but is not binding and does not establish rights. You may use an alternative approach if it satisfies applicable statutes and regulations.
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Key Dates
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