FDAnews Drug Daily Bulletin

FDA Needs Independent Ethics Board to Assess Postmarket Studies

Aug. 31, 2012
An independent ethics advisory board could help the FDA assess the risks and benefits of approved drugs and firm up its decisionmaking on required postmarket trials, according to a new report that advocates creating such a group. The impartial board could also assist in handling the added postmarket oversight that comes with responding to increased congressional and industry calls for more fast-tracked products. Such products can receive quicker drug approvals using more limited evidence, an article published Aug. 22 in the New England Journal of Medicine states.
Clinical Trials Advisor