RT Journal
A1 Kuehn BM
T1 IOm advises fda on ethics in postmarket safety trials
JF JAMA
JO JAMA
YR 2010
FD August 11
VO 304
IS 6
SP 627
OP 627
DO 10.1001/jama.2010.1080
UL http://dx.doi.org/10.1001/jama.2010.1080
AB 
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.