Considerations for the Development of Chimeric Antigen Receptor T Cell Products; Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products; Guidance for Industry." The guidance is intended to assist sponsors, including industry and academic sponsors, developing ex vivo- manufactured CAR T cell products. The guidance provides CAR T cell specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and design of clinical studies for oncology indications (including hematologic malignancies and solid tumors). The guidance announced in this notice finalizes the draft guidance of the same title dated March 2022.