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Whistleblower Management: Rogue FDA Reviewer Sets Tone to Start Avandia Committee; Forgotten By End

This article was originally published in RPM Report

Executive Summary

Avandia has been a contentious topic for FDA for six years. The latest advisory committee review highlights how far the agency has come in handling dissent – but also underscores the impact that a lone voice can have on delaying reviews, and prompting damaging headlines.

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With bigger clinical trials come potentially bigger problems. That, at least, is what sponsors of 15,000-plus trials in cardiovascular medicine are finding out. J&J/Bayer’s experience in late May with Xarelto for acute coronary syndrome is a case in point—and it also provides timely context for the surprising setback for another CV project, Pfizer/BMS' Eliquis.

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