TY  - JOUR
T1  - EXpedited review of new drugs—reply
AU  - Moore TJ, Furberg CD
Y1  - 2013/01/16
N1  - 10.1001/jama.2012.56920
JO  - JAMA
SP  - 236
EP  - 237
VL  - 309
IS  - 3
N2  - 
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.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2012.56920
UR  - http://dx.doi.org/10.1001/jama.2012.56920
ER  -