Reasons for Rejection of Patient-Reported Outcome Label Claims: A Compilation Based on a Review of Patient-Reported Outcome Use among New Molecular Entities and Biologic License Applications, 2006

Reasons for Rejection of Patient-Reported Outcome Label Claims: A Compilation Based on a Review of Patient-Reported Outcome Use among New Molecular Entities and Biologic License Applications, 2006–2010

Published:2012-05 Issue:3 Volume:15 Page:443-448
ISSN:1098-3015
Container-title:Value in Health
language:en
Short-container-title:Value in Health

Author:

DeMuro Carla,Clark Marci,Mordin Margaret,Fehnel Sheri,Copley-Merriman Catherine,Gnanasakthy Ari

Publisher

Elsevier BV

Subject

Public Health, Environmental and Occupational Health,Health Policy

Reference5 articles.

1. A review of patient-reported outcomes labels in the US: 2006–2010;Gnanasakathy;Value Health,2012

2. Measuring treatment impact: a review of patient-reported outcomes and other efficacy end points in approved product labels;Willke;Control Clin Trials,2004

3. PRO labeling claims in antineoplastic agents;Caron;Value Health,2010

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