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Tearing Down The Goalposts (Part 2): Diabetes Debate Has Toned Down At US FDA

 
• By Michael McCaughan

An October US FDA advisory committee meeting to discuss type 2 diabetes drug cardiovascular safety standards replayed a July 2008 meeting, but in a more harmonious key. That reflects the changing climate for FDA – but also a change in who was invited to participate.  

The Oct. 24-25 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee began with a very candid acknowledgement that it was, in many respects, a reprise of a July 1-2, 2008, meeting that led to the US FDA’s adoption of a requirement for cardiovascular outcomes trials for diabetes drugs in the first place.

FDA Division of Metabolism and Endocrinology Products Acting Director William Chong opened the meeting by noting that the so-called “goalpost” model for diabetes safety assessment was adopted following the advice...

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