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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

Abstract : 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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https://hal-sciencespo.archives-ouvertes.fr/hal-01521129
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Submitted on : Thursday, May 11, 2017 - 2:45:27 PM
Last modification on : Friday, October 15, 2021 - 5:20:02 PM

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Jean-David Zeitoun, Jérémie H. Lefevre, Nicholas Downing, Henri Bergeron, Joseph S. Ross. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study. British Journal of Clinical Pharmacology, Wiley, 2015, 80 (4), pp.716 - 725. ⟨hal-01521129⟩

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