FDA considers new trial standard for diabetes drugs

In a move that could have enormously costly implications for developers of new diabetes therapeutics, Pharmalot reports that the FDA has asked its Endocrinologic and Metabolic Drugs Advisory Committee to consider whether new therapies should undergo a clinical trial to test drugs for potential cardiovascular risks. The move comes after the agency added warnings to Actos and Avandia after researchers determined the drugs raised risks.

"Establishing a hurdle of long-term, costly trials to exclude cardiovascular harm may also affect drug development for type 2 diabetes," says an FDA briefing document, "particularly if this mandate applies to every product, even those that have no suggestion of cardiotoxicity."

- read the report [1] from Pharmalot

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