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The REMS Era Begins: FDA Applies Soft Touch With New Drug Safety Tools

This article was originally published in RPM Report

Executive Summary

Congress gave FDA some tough new tools to regulate drugs in September, but no one could know for sure how FDA would use them. Now there is some actual real world experience to judge by: a half-dozen drugs approved by FDA are subject to either a Risk Evaluation & Mitiagation Strategy or a mandatory post-marketing commitment. So far, the news is good for drug developers.

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