Regulation Text
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 .
Authority
21 U.S.C. 321,331,351,352,353,355,360,360c,360d,360h,360i,371,372,374,381;42 U.S.C. 216,262,263,263a,264.
Related Guidelines (6)
Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use (Status: Final)
→Guidance for Human Somatic Cell Therapy and Gene Therapy: Guidance for Industry (Status: Final)
→Potency Tests for Cellular and Gene Therapy Products: Final Guidance for Industry: (Status: Final)
→Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens (Status: Draft)
→Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry (Status: Final)
→Potency Assurance for Cellular and Gene Therapy Products (Status: Draft)
→