Federal Register #FDA2026D8561

FDA Draft Guidance on Potency Assessment for Active Immunotherapy Products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Food and Drug Administration (FDA), under the Department of Health and Human Services, is announcing the release of a draft guidance document focused on potency assessment for active immunotherapy products (ACTIMPs). - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - No OEMs or vendors are specified, as this is a regulatory guidance notice - Products/Services Requested: - No products or services are being procured - The guidance addresses peptide- and protein-based ACTIMPs, excluding cellular or gene therapy products - Unique or Notable Requirements: - The guidance provides recommendations for developing potency assays as part of a potency assurance strategy - Supplements previous guidance on cellular and gene therapy products - Public comments are requested on the draft guidance - Procedures for submitting comments, including confidential submissions, are outlined - No purchase quantities, part numbers, or procurement actions are involved - The notice is intended to inform industry practices and regulatory compliance for ACTIMPs

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document titled "Potency Assessment of Active Immunotherapy Products."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 The guidance supplements a December 2023 draft guidance on Potency Assurance for Cellular and Gene Therapy Products with additional advice specifically for ACTIMPs, including peptide- and protein-based products that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 Comments on the draft guidance are requested by November 18, 2026.

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