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FDA finalizes lifecycle potency assurance guidance for cell and gene therapies

Regulatory / securities filing · U.S. Food and Drug Administration

Source published: 2026-11-02 · Event / reporting date: 2026-11-02

Site published: 2026-11-05 · Updated: 2026-11-05

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Findings and limitations Industry implications Related developments

What changed

FDA announced final guidance on potency assurance for cellular and gene therapies on November 2. Its recommendations integrate manufacturing-process design, material and process controls, in-process testing, and lot-release potency assays. The agency emphasizes product-specific, risk-based strategies across development and commercialization; this is final guidance, not approval of any individual therapy.

Why it may matter

Analysis: Developers and analytical partners may need to connect potency methods more explicitly with process risks, critical attributes, and lifecycle controls.

The interpretation above is analysis, not a conclusion attributed to the original source.

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