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Key PointsQuestionWhat is the quality of clinical studies and data used to approve modifications to high-risk devices by the US Food and Drug Administration (FDA) panel-track supplement pathway? FindingsIn this descriptive study of 83 clinical studies for 78 panel-track supplements approved between 2006 and 2015, 45% were randomized clinical trials and 30% were blinded. Of the 150 primary end points in these studies, 81% were surrogates and 38% were compared with controls. MeaningThere are limitations in the quality of the studies and data evaluated by the FDA to support modifications of high-risk devices.
JAMA – American Medical Association
Published: Aug 15, 2017
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