# Potency Assessment of Active Immunotherapy Products - FDA Guidance Document

Source: https://www.keypedia.com/guidances/guidance-document/potency-assessment-of-active-immunotherapy-products/c0c49725-86ec-40cb-a98f-19549a1dd4e7

> FDA guidance document: Potency Assessment of Active Immunotherapy Products. Issue date: August 19, 2026. Get complete insights and analysis.

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## Details

- Title: Potency Assessment of Active Immunotherapy 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: 2026-08-19
- Last Changed: 2026-08-19
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2026-D-8561">FDA-2026-D-8561</a>

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