Trial Sponsors Urged to Get Early U.S. FDA Approval of PROs

International Pharmaceutical Regulatory Monitor
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Drug trial sponsors developing patient-reported outcome (PRO) measures should seek U.S. Food and Drug Administration (FDA) qualification for them prior to engaging in clinical trials, and should use the measures to gauge quality of life, Janet Woodcock, director of the U.S. Center for Drug Evaluation and Research, advises.

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