Avandia Re-Adjudication Might Result In “Refreshing” Restricted Distribution Roll Back
This article was originally published in The Pink Sheet Daily
Executive Summary
More than half of a 26-member advisory committee supports eliminating or easing the REMS for GSK’s diabetes drug, but the spilt vote and high-profile of the product’s safety issues suggest that FDA is unlikely to modify Avandia’s risk management.
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