A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have robust scientific and technical collaborations. As a window to the impact of these activities we compared the agencies’ decisions on drug marketing applications. Decisions were compared for 107 new drug applications...

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Detalles Bibliográficos
Autores principales: Kashoki, Mwango, Hanaizi, Zahra, Yordanova, Stella, Veselý, Richard, Bouygues, Christelle, Llinares, Jordi, Kweder, Sandra L.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6977394/
https://www.ncbi.nlm.nih.gov/pubmed/31306483
http://dx.doi.org/10.1002/cpt.1565

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6977394/
https://www.ncbi.nlm.nih.gov/pubmed/31306483
http://dx.doi.org/10.1002/cpt.1565

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