FDAnews Drug Daily Bulletin

FDA Needs Independent Ethics Board to Assess Postmarket Studies

Aug. 31, 2012
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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.
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