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BioPharmaceutical Risk Management

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

This article was originally published in RPM Report

  • Analysis

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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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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