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Application of orphan drug designation to cancer treatments (2008–2017): a comprehensive and comparative analysis of the USA and EU

OBJECTIVE: To determine differences in the characteristics of cancer drugs designated as orphan drugs by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). DESIGN AND SETTING: Identification of all cancer drugs (initial or supplementary indication) with orphan status approve...

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Detalles Bibliográficos
Autores principales:	Vokinger, Kerstin Noëlle, Kesselheim, Aaron S
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2019
Materias:	Health Policy
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797305/ https://www.ncbi.nlm.nih.gov/pubmed/31601584 http://dx.doi.org/10.1136/bmjopen-2018-028634

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