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Getting With The PRO-gram: Making Patient-Reported Outcomes Work

This article was originally published in RPM Report

Executive Summary

When FDA’s guidance document on patient-reported outcomes was finalized five years ago, it was lauded as a milestone event for an industry interested in advancing patient-centered drug development. But implementation of the guidance hasn’t gone the way some had hoped – and actually may be dissuading sponsors from pursuing PRO labeling claims. Can FDA’s patient-centered drug development initiative help?


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