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The REMS Ramp Up: FDA Using New Safety Tools More Frequently In Year Two

This article was originally published in RPM Report

Executive Summary

FDA has invoked formal Risk Evaluation & Mitigation Strategy Authority almost as often the last five months as it did in the first full year of the program. Use of more intense REMS-those with communication plans and elements to assure safe use-is increasing even faster, and indications are this is the leading edge of a wave of new restrictive programs. REMS unquestionably delay approvals, FDA officials acknowledge-and yet, more drugs are coming out of FDA.

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