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REMS Redesign: FDA's Opening Statement to Stakeholders

This article was originally published in RPM Report

Executive Summary

Center for Drug Evaluation & Research Director Janet Woodcock kicked off FDA’s two day feedback meeting on the REMS July 27 with a construction analogy: FDA is still in the process of building a new house, but it is clear that there needs to be a redesign. Here are her opening remarks, from the official transcript of the meeting.

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