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

Value in Health

Volumn 15, Issue 3, 2012, Pages 443-448

  Demuro, Carla ^a   Clark, Marci ^a   Mordin, Margaret ^a   Fehnel, Sheri ^a   Copley Merriman, Catherine ^a   Gnanasakthy, Ari ^b  

^a RTI HEALTH SOLUTIONS   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

label claims; patient reported outcomes; rejection

Indexed keywords

CLINICAL TRIAL (TOPIC); DRUG APPROVAL; DRUG LABELING; DRUG PACKAGING; FOOD AND DRUG ADMINISTRATION; HUMAN; LICENCE; OUTCOME ASSESSMENT; PATIENT REPORTED OUTCOME; PRIORITY JOURNAL; REVIEW;

EID: 84861174759     PISSN: 10983015     EISSN: 15244733     Source Type: Journal    
DOI: 10.1016/j.jval.2012.01.010     Document Type: Article

References (6)

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