The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011–2018

BACKGROUND: In situations of unmet medical need or in the interests of public health, expedited approval pathways, including conditional marketing authorisation (CMA) and accelerated assessment (AA), speed up European Medicines Agency (EMA) marketing authorisation recommendations for medicinal produ...

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Detalles Bibliográficos
Autores principales: Schuster Bruce, Catherine, Brhlikova, Petra, Heath, Joseph, McGettigan, Patricia
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2019
Materias:
Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6736244/
https://www.ncbi.nlm.nih.gov/pubmed/31504034
http://dx.doi.org/10.1371/journal.pmed.1002873

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