Avandia Trial Re-Adjudication Beyond FDA’s Abilities, Agency Officials Say
This article was originally published in The Pink Sheet Daily
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.
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Flawed clinical trial overcomes meta-analysis safety signal as mortality data from the re-adjudicated RECORD trial persuades the rosiglitazone advisory committee that the product’s risk management program can be relaxed.
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.
Two advisory panels will revisit the question of whether FDA should withdraw GlaxoSmithKline’s Avandia from the market as a reevaluation of the cardiovascular trial produces results similar to the original findings; the data does not seem to offer much more clarity, but does give the agency a chance to argue it handled previous controversies well.