[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Citations 0
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.

First Page Preview View Large
First page PDF preview
First page PDF preview