Federal Register #FDA-2026-D-8561

FDA Draft Guidance on Potency Assessment for Active Immunotherapy Products

The Food and Drug Administration (FDA), under the Department of Health and Human Services, is announcing the release of a draft guidance document regarding potency assessment for active immunotherapy products (ACTIMPs). - No procurement is involved; this is a policy guidance announcement. - No OEMs, vendors, or product/service requests are mentioned. - The guidance focuses on developing assays for potency assurance in peptide- and protein-based ACTIMPs (excluding cellular and gene therapy products). - Supplements previous guidance on potency assurance for cellular and gene therapy products. - Public comments are requested on the draft guidance; instructions for submission are provided. - No unique technical or procurement requirements are specified.

Description

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document titled "Potency Assessment of Active Immunotherapy Products." This draft provides recommendations for developing assays to assess potency as part of a potency assurance strategy for active immunotherapy products (ACTIMPs). The guidance supplements a December 2023 draft guidance on Potency Assurance for Cellular and Gene Therapy Products with additional advice specifically for ACTIMPs, including peptide- and protein-based products that are not cellular or gene therapy products. Comments on the draft guidance are requested by November 18, 2026.

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