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Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

 

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Type:   Article
 
Titre:   Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study
 
Auteur(s):   Zeitoun, Jean-David - Service de Gastroentérologie et nutrition (Auteur)
Lefèvre, Jérémie H. - Hôpital Beaujon (Auteur)
Downing, Nicholas - Brigham and Women's Hospital (Boston) (Auteur)
Bergeron, Henri (1966-...) - Centre de sociologie des organisations (Auteur)
Ross, Joseph S. - Yale School of Medicine (Auteur)
 
In:   British Journal of Clinical Pharmacology
 
Date de publication:   2015-10
 
Volume:   80
 
Numéro:   4
 
Pages:   716-725  p.
 
DOI:   10.1111/bcp.12643
 
Mots-clés:   [en] European Medicines Agency, drug approval, government regulation
 
Résumé:   [en] Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA).
 
 

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