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To REMS Or Not To REMS? Erivedge Shows Division At FDA Over Oncology Risk Management

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

The review division and CDER senior staff supported approval of Genentech’s highly teratogenic, basal cell carcinoma treatment vismodegib without a Risk Evaluation and Mitigation Strategy, but the Division of Risk Management believed a communications plan should be carried out under a REMS for the first-in-class Hedgehog pathway inhibitor.

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