IOM advises FDA on ethics in postmarket safety trials.

摘要

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