Tearing Down The Goalposts: What’s Next For US FDA Diabetes Guidelines?

 
• By Michael McCaughan

Advisory committee discussion of cardiovascular safety standards for type 2 diabetes therapies was a friendly, collegial event with broad agreement on how FDA’s diabetes guidelines can be improved. Unfortunately, the panel split down the middle on the critical question for FDA.

Students at a college game tearing down the goalposts
These are unruly college students, not pharmaceutical executives after the advisory committee.

The chair of the US FDA’s Endocrinologic & Metabolic Drugs Advisory Committee offered an especially apt summary of the panel’s Oct. 24-25 discussion of elements of FDA’s safety standards for diabetes drugs: "Everybody said they were saying the same thing, but you all said something different."

The chair, Emory University’s Peter Wilson, was attempting to summarize the specific points made in response to a question about...

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