#FDA Fails to Track Postmarket Drug Studies Sufficiently : #GAO
▻http://www.medscape.com/viewarticle/857546
The US Food and Drug Administration (FDA) is not doing a good job of tracking the clinical effectiveness or the safety of drugs with expedited approval after they have been released to the market, according to a new report from the General Accountability Office (GAO).
Previous government reports in 2006 and 2009 found that the FDA was not meeting its responsibilities in tracking postmarket studies of approved drugs. Similarly, the new GAO report states, “FDA lacks reliable, readily accessible data on tracked safety issues and postmarket studies needed to meet certain postmarket safety reporting responsibilities and to conduct systematic oversight.”