A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016)

To compare US Food and Drug Administration (FDA) and European Medicines Agency (EMA) labeling for evidence based on patient-reported outcomes (PROs) of new oncology treatments approved by both agencies. Oncology drugs and indications approved between 2012 and 2016 by both the FDA and the EMA were id...

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Bibliographische Detailangaben
Veröffentlicht in:	Value in health 2019-02, Vol.22 (2), p.203-209
Hauptverfasser:	Gnanasakthy, Ari, Barrett, Amy, Evans, Emily, D'Alessio, Denise, Romano, Carla (DeMuro)
Format:	Artikel
Sprache:	eng
Schlagworte:	Antineoplastic Agents - standards Cancer Clinical outcomes Drug Approval Drug Labeling - legislation & jurisprudence Drug Labeling - standards Drugs Europe - epidemiology European Medicines Agency (EMA) Food and Drug Administration (FDA) Functional assessment Health status Healthy food Humans Labeling Language Neoplasms - drug therapy Neoplasms - epidemiology Oncology Patient Reported Outcome Measures patient-reported outcome (PRO) Patients Quality of life Randomized Controlled Trials as Topic - standards United States - epidemiology United States Food and Drug Administration - legislation & jurisprudence United States Food and Drug Administration - standards
Online-Zugang:	Volltext
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