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FDAAA Impact Analysis (Year 7): The Era of the “Breakthrough” REMS

This article was originally published in RPM Report

Executive Summary

FDA continues to use the formal Risk Evaluation & Mitigation Strategy authority very infrequently in the context of new drug approvals. There is one countervailing trend: the agency is imposing mandatory communication plans for some of the new oncology therapies – including two “Breakthroughs.”


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