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Medical News and Perspectives
August 11, 2010

IOM Advises FDA on Ethics in Postmarket Safety Trials

JAMA. 2010;304(6):627. doi:10.1001/jama.2010.1080

To ensure that FDA-mandated postmarket safety trials of medications meet appropriate ethical standards, the Institute of Medicine (IOM) has developed a framework to guide the agency in its decisions regarding such trials.

The IOM published the framework July 9, in advance of a larger report on postmarket drug safety due to be published in 2011 (http://www.nap.edu/catalog.php?record_id=12948). The Food and Drug Administration Amendments Act of 2007 (FDAAA) expanded the FDA authority to monitor postmarket safety of approved drugs, including requiring manufacturers to conduct postmarket safety trials.

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