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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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