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Avandia Advisory Committee Re-Review Reflects Well On FDA

Executive Summary

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
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