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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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Publicado no: | Br J Clin Pharmacol |
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Main Authors: | , , , , |
Formato: | Artigo |
Idioma: | Inglês |
Publicado em: |
John Wiley & Sons, Ltd
2015
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Assuntos: | |
Acesso em linha: | 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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