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Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims: draft guidance.
U.S. Department of Health and Human Services FDA Center for Drug Evaluation and Research , U.S. Department of Health and Human Services FDA Center for Biologics Evaluation and Research , U.S. Department of Health and Human Services FDA Center for Devices and Radiological Health
Health Qual Life Outcomes 2006, 4:79
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