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User Fees Risk Management Regulation

REMS Assessment Review Goals, Resources On The Table For PDUFA VII

  • Analysis

Executive Summary

US FDA proposes formal performance metrics for REMS assessment reviews, which would be part of a larger campaign to streamline the REMS assessment process.

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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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