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Critical Comments by the European Medicines Agency on Patient-Reported Outcomes in Regulatory Submissions (2020 to

Courtney Levy1, Sarah Sauchelli1, Jessica L Abel2

  • 1Patient-Centered Outcomes Assessment, RTI Health Solutions, Manchester, England, UK.

Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research
|June 24, 2026
PubMed
Abstract

Keywords:
European Medicines Agency (EMA)Patient-reported outcome (PRO)Summary of Product Characteristics (SmPC)clinical trialspackage leafletpatient-reported outcome measure (PROM)

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