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Avandia Trial Re-Adjudication Beyond FDA’s Abilities, Agency Officials Say

 
• By Cathy Dombrowski

FDA had only a portion of the information needed to conduct a re-adjudication, Bob Temple tells advisory committee during the first of a two-day discussion of rosiglitizone’s cardiovascular safety.

FDA has neither the information, the process nor the resources to re-adjudicate clinical trial data, agency officials told the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees June 5 during day one of a two-day session to reconsider the cardiovascular risk of GlaxoSmithKline PLC’s Avandia (rosiglitazone maleate).

That reconsideration is based on re-adjudication of the cardiovascular events in the RECORD cardiovascular outcomes trial by Duke Clinical Research Institute Also see "Avandia Advisory Committee: Can Poking Old Wounds Be Good For FDA

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