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Roche & Generic Firms Propose SMART-er Accutane Risk Management Program

This article was originally published in The Pink Sheet Daily

Executive Summary

"Consensus proposal" includes mandatory registration of female patients and prescribers. The proposed enhancements to SMART incorporate aspects of Celgene's STEPS program for Thalomid, but avoid restricted distribution.

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Accutane Risk Management Program Changes Held Up By Celgene Patents

Four patents relating to the STEPS risk management program for Thalomid are an “obstacle” to implementing an augmented isotretinoin program, FDA says. The agency’s Office of Chief Counsel is reviewing the issue.

Myovant’s Relugolix Won’t Be Stopped By Missed Endpoint

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