Using Business Intelligence for Strategic Advantage in REMS

Kurt Kessler, Ashwin Mathias, Sudhanshu Bhatnagar

The FDA has mandated Risk Evaluation and Mitigation Strategy (REM) programs to manage risks associated with drugs. REMS programs comprise elements to assure safe use (ETASUs), and companies need to implement some (least restrictive) to all ETASUs (most restrictive) required by the FDA.

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