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REMS Redesign: What FDA Heard From Stakeholders

This article was originally published in RPM Report

Executive Summary

CDER Associate Director for Policy Jane Axelrad chaired the two day stakeholder meeting on REMS July 27-28, and delivered a remarkably cogent summary of about 15 hours presentations and discussion before adjourning the event. Here is here summary of the key takeaways from the meeting, excerpted from the official FDA transcript of the event.

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