Advancing CAR T-Cell Therapy
Upendra Mahat, Asha Das, Vijay Kumar, Vinay Prasad
Abstract
This Viewpoint discusses the recent decision by the US Food and Drug Administration to eliminate Risk Evaluation and Mitigation Strategies requirements for chimeric antigen receptor (CAR) T-cell therapies for the treatment of cancer.
Topics & Concepts
MedicineChimeric antigen receptorFood and drug administrationIntensive care medicineRisk analysis (engineering)Drug administrationDrugMEDLINEDrug approvalAdministration (probate law)Risk assessmentMedical emergencyPharmacologyPatient safetyPharmacotherapyCAR-T cell therapy researchBiomedical and Engineering EducationBiomedical Ethics and Regulation