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Memo To File: FDA Managers Rebut Rogue Reviewer

This article was originally published in RPM Report

Executive Summary

Here is a May 14 memo “to the file” signed by ODE I Director Ellis Unger, Deputy Director Robert Temple and Cardio-Renal Drug Products Division Director Norman Stockbridge, responding to the “unsolicited” reviews of Avandia submitted by cardio-renal division reviewer Thomas Marciniak. It was included in the briefing documents provided to the FDA advisory committee ahead of a June 5-6 meeting.

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