Health Law Daily Wrap Up, DRUGS AND BIOLOGICS—FDA GUIDANCE NOTICES: Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability, (Aug 21, 2026)

By WK Editorial Staff

The FDA 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The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products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 This guidance is intended to supplement the December 2023 draft guidance for industry, when finalized, on “Potency Assurance for Cellular and Gene Therapy Products” with additional advice and considerations specifically for ACTIMPs,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. (Notice, 91 Fed. Reg. 53880 (Aug. 20, 2026)).

Dates. Submit either electronic or written comments on the draft guidance by November 18, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

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