Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study - Sciences Po Access content directly
Journal Articles British Journal of Clinical Pharmacology Year : 2015

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).

Domains

Sociology

Dates and versions

hal-01521129 , version 1 (11-05-2017)

Identifiers

Cite

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, 2015, 80 (4), pp.716 - 725. ⟨10.1111/bcp.12643⟩. ⟨hal-01521129⟩
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