Expanded Access as a source of real‐world data: An overview of FDA and EMA approvals

AIMS: To identify, characterize and compare all Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals that included real‐world data on efficacy from expanded access (EA) programmes. METHODS: Cross‐sectional study of FDA (1955–2018) and EMA (1995–2018) regulatory approval d...

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Detalles Bibliográficos
Autores principales: Polak, Tobias B., van Rosmalen, Joost, Uyl – de Groot, Carin A.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2020
Materias:
Original Articles
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444779/
https://www.ncbi.nlm.nih.gov/pubmed/32200551
http://dx.doi.org/10.1111/bcp.14284

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7444779/
https://www.ncbi.nlm.nih.gov/pubmed/32200551
http://dx.doi.org/10.1111/bcp.14284

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