# Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/guidance-for-industry-potency-assurance-for-cellular-and-gene-therapy-products/b0c71ebb-a023-4038-8713-7a43757441d1

> FDA guidance document: Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products. Issue date: November 02, 2026. Get complete insights and analysis.

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## Details

- Title: Guidance for Industry: Potency Assurance for Cellular and Gene Therapy Products
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Biologics Evaluation and Research
- Office URL: /offices/center-for-biologics-evaluation-and-research/dd9e8ea7-6f04-4ed1-b0d7-e7e6b264570d
- Issue Date: 2026-11-02
- Last Changed: 2026-11-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-4299">FDA-2023-D-4299</a>

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