Issue Date: August 20, 2026
Issued by: Center for Biologics Evaluation and Research,Office of Therapeutic Products
Topic(s): Biologics, Gene Therapy
Status: Draft
Potency Assessment of Active Immunotherapy Products
This draft guidance provides recommendations for developing assays to evaluate potency as part of a potency assurance strategy for active immunotherapy products (ACTIMPs), including peptide- and protein-based ACTIMPs that are not cellular or gene therapy products. It supplements FDA’s December 2023 draft guidance “Potency Assurance for Cellular and Gene Therapy Products,” and when finalized will describe FDA’s current thinking on designing, validating, and evaluating potency tests for these products.
Download the Guidance Document
