To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016

OBJECTIVE: To compare review outcome alignment between European Medicines Agency (EMA) and US Food and Drug Administration (FDA) for medicines approved by both agencies in the time period 2014–2016. DESIGN: Using publicly available information from FDA and EMA websites, new active substances (NASs)...

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Detalles Bibliográficos
Autores principales: Kühler, Thomas Christian, Bujar, Magda, McAuslane, Neil, Liberti, Lawrence
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2019
Materias:
Public Health
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6887045/
https://www.ncbi.nlm.nih.gov/pubmed/31772082
http://dx.doi.org/10.1136/bmjopen-2018-028677

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