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US FDA May Change Requirements For CV Outcomes Trials For Type 2 Diabetes Drugs

 
• By Brenda Sandburg

Endocrinologic and Metabolic Drugs Advisory Committee will reconsider 2008 guidance on evaluating CV risks in antidiabetic therapies at two-day meeting in October.

Diabetes

Ten years after a US FDA advisory committee called on the agency to require cardiovascular outcomes trials for all type 2 diabetes drug candidates, the agency is reconvening the panel, apparently to consider the ongoing need for, and design of, these studies.

In a Federal Register notice scheduled for publication Sept. 18, FDA announced that the Endocrinologic and Metabolic Drugs Advisory Committee will meet Oct

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