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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

AIMS: 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...

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Detaylı Bibliyografya
Yayımlandı:Br J Clin Pharmacol
Asıl Yazarlar: Zeitoun, Jean-David, Lefèvre, Jérémie H, Downing, Nicholas S, Bergeron, Henri, Ross, Joseph S
Materyal Türü: Artigo
Dil:Inglês
Baskı/Yayın Bilgisi: John Wiley & Sons, Ltd 2015
Konular:
Online Erişim:https://ncbi.nlm.nih.gov/pmc/articles/PMC4594708/
https://ncbi.nlm.nih.gov/pubmed/25808713
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/bcp.12643
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