The US Government Accountability Office is to review a drug approval process used by the FDA

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  • PharmacoEconomics & Outcomes News 551 - 19 Apr 2008

    The US Government Accountability Office is toreview a drug approval process used by the FDA thatevaluates efficacy and safety of drugs based onsurrogate end points in clinical trials. Senator ChuckGrassley requested the review, saying that the FDAhad approved several drugs, including bevacizumaband rosiglitazone, based on their effectiveness atachieving surrogate end points (such as limitingtumour growth), without demonstrating whether ornot the drugs actually protected lives and improvedhealth.Surrogate end points queried. JAMA: the Journal of the American MedicalAssociation 299: 1657, No. 14, 9 Apr 2008 801034992

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    PharmacoEconomics & Outcomes News 19 Apr 2008 No. 5511173-5503/10/0551-0001/$14.95 Adis 2010 Springer International Publishing AG. All rights reserved