RT Journal
A1 Mitka M
T1 POstmarket studies lag
JF JAMA
JO JAMA
YR 2009
FD December 9
VO 302
IS 22
SP 2423
OP 2423
DO 10.1001/jama.2009.1802
UL http://dx.doi.org/10.1001/jama.2009.1802
AB 
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.