Review Of GSK's Avandia Trial Flawed, FDA Official Says

Law360, New York (June 5, 2013, 5:06 PM EDT) -- A U.S. Food and Drug Administration official on Wednesday blasted a Duke University research group's re-examination of a GlaxoSmithKline PLC trial for the former blockbuster diabetes treatment Avandia, charging that the group's ties to the drugmaker compromised its analysis.

Two FDA advisory committees are holding a two-day meeting to determine whether they believe the agency should lift, maintain or increase restrictions on the sale of Avandia put in place in 2010, after the drug was linked to an increased risk of heart attacks.

At issue is...
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