Tests for potency shall consist of either in vitro or in vivo tests, or both, which have been specifically designed for each product so as to indicate its potency in a manner adequate to satisfy the interpretation of potency given by the definition in § 600.3(s) of this chapter .
21 CFR Part 610 · General Biological Products Standards
§ 610.10 Potency
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FDA guidance that cites § 610.10
- Potency Assessment of Active Immunotherapy Products draft 19 Aug 2026
- Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause draft 23 Feb 2026
- Potency Assurance for Cellular and Gene Therapy Products draft 27 Dec 2023
- Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens draft 1 Mar 2023
- BLA for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System: Guidance for Industry 1 Mar 2014
- Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry: 1 Jan 2011
- Considerations for Allogeneic Pancreatic Islet Cell Products: Guidance for Industry 1 Sept 2009
- Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for Industry 1 Mar 1998
- Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use 28 Feb 1997
Amendment history
Federal Register documents that created or amended this section.
- 38 FR 32056 20 Nov 1973