FDA reconsidering diabetes drug approval process

Tue, 01 Jul 2008
According to recent reports, government regulators in America are thinking through how they approve drugs . The revision to FDA processes comes about following widespread criticism relating to Avandia, the GlaxoSmithKline diabetes drug linked to an increased level of heart risks.

The Food and Drug Administration is set to speak to a leading panel of diabetes experts, statisticians and cardiologists in the next few days. The experts will demonstrate factors relating to risk that could influence the approval process of the FDA.

If the FDA chooses to accept a new standard approval process, pharmaceutical companies may have put drugs through longer, more expensive clinical trials . The FDA has been under pressure to adopt standards of this type for some time. Further news relating to drug approval decisions will be reported as they happen.
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