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

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.

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Bibliografiske detaljer
Udgivet i:JAMA Intern Med
Main Authors: Doshi, Peter, Spence, O’Mareen, Kuzucan, Aida, Powers, John H.
Format: Artigo
Sprog:Inglês
Udgivet: American Medical Association 2019
Fag:
Research Letter
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC6503639/
https://ncbi.nlm.nih.gov/pubmed/30830158
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2018.7040
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