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Potency Assessment of Active Immunotherapy Products; Draft Guidance for Industry; Availability
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Summary (from the Federal Register abstract)
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 The draft guidance document provides recommendations for developing assays to assess potency as a part of a potency assurance strategy for active immunotherapy products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 This guidance is intended to supplement the December 2023 draft guidance for industry, when finalized, on "Potency Assurance for Cellular and Gene Therapy Products" with additional advice and considerations specifically for ACTIMPs,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.
- Document type
- Notice
- Federal Register document number
- 2026-16960
- Published
- Aug 20, 2026
- Action
- Notice of availability.
- Docket
- FDA-2026-D-8561
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by November 18, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- CMC (chemistry, manufacturing & controls) Vaccines / biologics
Source: Federal Register API, document 2026-16960. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.