RT Journal
A1 Moore TJ, Furberg CD
T1 EXpedited review of new drugs—reply
JF JAMA
JO JAMA
YR 2013
FD January 16
VO 309
IS 3
SP 236
OP 237
DO 10.1001/jama.2012.56920
UL http://dx.doi.org/10.1001/jama.2012.56920
AB 
In our recent review of FDA postmarketing actions taken in 2009,1 we identified 181 major safety changes, including 25 new boxed warnings and 19 contraindications, occurring a median of 11 years after approval. While marketing approval now comes quickly, we are concerned that postmarketing safety actions frequently take years and do not fully resolve the safety problems.