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Article dans une revue

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
Contributeur : Spire Sciences Po Institutional Repository <>
Soumis le : jeudi 11 mai 2017 - 14:45:27
Dernière modification le : vendredi 2 juillet 2021 - 13:59:53

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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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