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Communication of Nonefficacy Benefits of New Drugs Approved on the Basis of Noninferiority Trials Alone: Cohort Study of FDA and Sponsor Communication, 2011-2017

Authors :
Aida Kuzucan
John H. Powers
O'Mareen Spence
Peter Doshi
Source :
JAMA internal medicine. 179(5)
Publication Year :
2019

Abstract

This cohort study of FDA- and drug sponsor–written communications evaluates the communication of nonefficacy benefits of new drugs approved on the basis of noninferiority trials alone.

Details

ISSN :
21686114
Volume :
179
Issue :
5
Database :
OpenAIRE
Journal :
JAMA internal medicine
Accession number :
edsair.doi.dedup.....ae61d019fe5f2d812065055569aa0291