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CDER Offices Go Public With “Fundamental Disagreement” Over Avandia

Executive Summary

Political pressure from FDA outsiders interested in improving drug safety oversight may have backfired, resulting in an embarrassing advisory committee meeting for the agency. The July 30 review of a cardiovascular safety signal for GlaxoSmithKline's diabetes drug Avandia became a forum to play out another controversy between the Office of New Drugs and the Office of Surveillance and Epidemiology

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The FDA advisory committee re-review of cardiovascular safety risks with GlaxoSmithKline's Avandia (rosiglitazone) will not end calls from agency critics to create a separate drug safety center. However, the transparency of internal scientific disputes on display at the July 13-14 meeting and the committee's recommendations could take some ammunition away from those who assert the Center for Drug Evaluation and Research has given short shrift to safety issues

Avandia Advisory Committee Re-Review Reflects Well On FDA

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Participants in the ongoing safety debate over GlaxoSmithKline's Avandia (rosiglitazone) are refining their arguments ahead of the July 13-14 joint FDA advisory committee meeting on the troubled thiazolidinedione's future

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