GAO to investigate FDA approval process

03/4/2008 | San Diego Union-Tribune

The Government Accountability Office has agreed to investigate the FDA's drug-approval process, which cleared the drugs Vytorin and Avandia despite concerns over their safety and efficacy. One question facing the GAO is whether the agency should rely on biological measures -- such as cholesterol and blood-sugar levels -- if it lacks proof that the treatment can improve more important outcomes, such as patient survival.

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San Diego Union-Tribune

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