Home » Trial Sponsors Urged to Get Early U.S. FDA Approval of PROs
Trial Sponsors Urged to Get Early U.S. FDA Approval of PROs
December 9, 2011
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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