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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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| Publicado no: | BMJ Open |
|---|---|
| Main Authors: | , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
BMJ Publishing Group
2019
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC6887045/ https://ncbi.nlm.nih.gov/pubmed/31772082 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmjopen-2018-028677 |
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