Type
Article
Title
Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study
Author(s)
ZEITOUN Jean-David - Service de Gastroentérologie et nutrition (Author)
LEFÈVRE Jérémie H. - Hôpital Beaujon (Author)
DOWNING Nicholas - Brigham and Women's Hospital (Boston) (Author)
BERGERON Henri - Centre de sociologie des organisations (Author)
ROSS Joseph S. - Yale School of Medicine (Author)
Volume
80
Number
4
Pages
716 - 725 p.
DOI
10.1111/bcp.12643
Keywords
European Medicines Agency, drug approval, government regulation
Abstract
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).
BIBLIOGRAPHIC QUOTE
EXPORT