Grassley Wants An Rx Safety Reorganization; Can FDA Keep Him At Bay Again? Congressional Avandia Investigation Reopens Door On Splitting CDER
Renewed congressional interest in a separate drug safety center at FDA is a likely off-shoot of a Senate Finance Committee report that questions GlaxoSmithKline's handling of cardiovascular safety issues surrounding Avandia
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A re-adjudication of cardiovascular events in the RECORD trial reassured members of a June 5-6 advisory committee that the study findings are reliable, but did not erase uncertainties about CV risk associated with rosiglitazone.
Company's internal e-mails suggest GSK hid vital studies related to safety of Avandia relative to competitor, senators charge.
Rep. Rosa DeLauro's, D-Conn., hearing on the safety of GlaxoSmithKline's diabetes drug Avandia has ratcheted up the pressure on FDA to make broad reforms of its review structure, but the congresswoman has been careful not to urge a particular course of action for the agency