TY  - JOUR
T1  - POstmarket studies lag
AU  - Mitka M
Y1  - 2009/12/09
N1  - 10.1001/jama.2009.1802
JO  - JAMA
SP  - 2423
EP  - 2423
VL  - 302
IS  - 22
N2  - 
The GAO report, requested by Sen Chuck Grassley (R, Iowa) and released October 26, found that postmarketing studies had been completed for only about two-thirds of the 90 drug applications approved under the FDA's accelerated program between 1992 and 2008 (http://www.gao.gov/new.items/d09866.pdf). The GAO added that although the FDA can expedite the withdrawal of a drug from the market if a company does not complete a postmarketing study with due diligence or if a study fails to confirm clinical benefit, the agency has never done so.

SN  - 0098-7484
M3  - doi: 10.1001/jama.2009.1802
UR  - http://dx.doi.org/10.1001/jama.2009.1802
ER  -