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

Jean-David Zeitoun; Jérémie H. Lefevre; Nicholas Downing; Henri Bergeron; Joseph S. Ross

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

Jean-David Zeitoun ^{1, 2} Jérémie H. Lefevre ³ Nicholas Downing ⁴ Henri Bergeron ⁵ Joseph S. Ross ⁶

1 Service de Gastroentérologie et nutrition [CHU Saint-Antoine]

2 Dpt proctologie [CHU Croix St Simon]

3 Hôpital Beaujon

4 Brigham and Women's Hospital [Boston]

5 CSO - Centre de sociologie des organisations

6 Yale University School of Medicine

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).

Keywords : European Medicines Agency drug approval government regulation

Type de document :

Article dans une revue

Domaine :

Sciences de l'Homme et Société / Sociologie

Liste complète des métadonnées

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

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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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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