Health Policy AnalysisA Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016)
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Keywords
European Medicines Agency (EMA)
Food and Drug Administration (FDA)
labeling
oncology
patient-reported outcome (PRO)
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Conflicts of interest: A. Gnanasakthy, A. Barrett, E. Evans, and C. Romano are salaried employees of RTI Health Solutions. D. D'Alessio is a salaried employee of Novartis Pharmaceuticals Corporation.
© 2019 ISPOR-The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc.