IOM Report Establishes Parameters For Postmarket Drug Studies

April Hollis

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IOM Report Establishes Parameters For Postmarket Drug Studies

机译：IOM报告为上市后药物研究确定参数

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The FDA should require postmarket safety studies for drugs only after other assessment methods have been ruled out in order to ensure patient safety, according to an Institute of Medicine (IOM) letter report conducted at the agency's request.rnBefore a postmarket study is ordered, the FDA should determine that no other information-gathering method, including a new observational study, could sufficiently answer safety questions, the report released July 9 says.

机译：根据该机构要求的医学研究所（IOM）信函报告，FDA仅应在排除其他评估方法以确保患者安全之后才要求对药物进行上市后安全性研究。rn在订购上市后研究之前， 7月9日发布的报告称，FDA应该确定没有其他信息收集方法（包括新的观察性研究）能够充分回答安全性问题。

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《Washington Drug Letter》 |2010年第28期|P.7|共1页
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April Hollis;
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IOM Report Establishes Parameters For Postmarket Drug Studies

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