Patient-Reported Outcomes to Support Medical Product Labeling Claims: FDA Perspective
Donald L. Patrick(United States Food and Drug Administration), Laurie B. Burke(Center for Drug Evaluation and Research), John H. Powers(National Institutes of Health), Jane Scott, Edwin P. Rock(GlaxoSmithKline (United States)), Sahar Dawisha(Center for Devices and Radiological Health), Robert T. O’Neill(Center for Drug Evaluation and Research), Dianne L. Kennedy(Center for Drug Evaluation and Research)
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