FDA Changes CAR-T REMS Education, Adverse Event Reporting Requirements

FDA Changes CAR-T REMS Education, Adverse Event Reporting Requirements | FDAnews

Changes to the Risk Evaluation and Mitigation Strategy (REMS) for all six approved CAR-T cell therapies remove the requirement for providers to engage in specific educational activities and allow them to report adverse events directly to the FDA’s MedWatch reporting system.

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