FDA eliminates REMS for approved CAR-T therapies | RAPS
Regulatory NewsJoanne S. EglovitchBiologics/ biosimilars/ vaccinesBiotechnologyCBERHuman cells, tissues, and cellular and tissue-based products (HCT/Ps)Quality Assurance and ControlRegulatory Intelligence/PolicyREMSRisk managementUnited StatesUS Food and Drug Administration (FDA)
