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It's Up To Stakeholders To Further The PRO Measurement Field, FDA Said

Executive Summary

FDA is preparing to issue its final guidance on patient-reported outcomes soon - which will codify the agency's approach to validating PROs used as clinical endpoints - but a recent workshop made clear that there is still a substantial amount of work to be done on identifying and creating appropriate measurements of patient-, clinician- and caregiver-reported outcomes

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FDA's Final PRO Guidance Grounds Policy With More Details

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