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Avandia Should Stay On Market With Warnings, Committee Says

Executive Summary

FDA's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees are calling for strengthened warnings for GlaxoSmithKline's type 2 diabetes drug Avandia due to cardiovascular safety concerns, but not its withdrawal from the market

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Avandia Advisory Cmte. Is FDA's Primary Response To Congressional Pressure

Sponsors will get another look in July at how FDA interprets guidance for assessing the cardiovascular risk of diabetes drugs in clinical trials. The venue will be a meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees

Avandia Advisory Cmte. Is FDA's Primary Response To Congressional Pressure

Sponsors will get another look in July at how FDA interprets guidance for assessing the cardiovascular risk of diabetes drugs in clinical trials. The venue will be a meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees

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