The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft document titled "Potency Assessment of Active Immunotherapy Products." The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products (ACTIMPs). When finalized, this guidance will describe the FDA's current thinking regarding design, validation, and evaluation of potency tests for ACTIMPs. This guidance is intended to supplement the December 2023 draft guidance for industry, when finalized, on "Potency Assurance for Cellular and Gene Therapy Products" with additional advice and considerations specifically for ACTIMPs, including peptide- and-protein based ACTIMPs that are not cellular or gene therapy products.
US Federal Register - FDA Guidance Notices · August 20, 2026
Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry
Original title: Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability
FDA announces draft guidance on designing, validating and evaluating potency assays for active immunotherapy products including peptide and protein-based ACTIMPs.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.