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PharmacoEconomics & Outcomes News 551 - 19 Apr 2008 ■ The US Government Accountability Office is to review a drug approval process used by the FDA that evaluates efficacy and safety of drugs based on surrogate end points in clinical trials. Senator Chuck Grassley requested the review, saying that the FDA had approved several drugs, including bevacizumab and rosiglitazone, based on their effectiveness at achieving surrogate end points (such as limiting tumour growth), without demonstrating whether or not the drugs actually protected lives and improved health. Surrogate end points queried. JAMA: the Journal of the American Medical Association 299: 1657, No. 14, 9 Apr 2008 801034992 1 PharmacoEconomics & Outcomes News 19 Apr 2008 No. 551 1173-5503/10/0551-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: The US Government Accountability Office is to review a drug approval process used by the FDA

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

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