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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...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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BMJ Publishing Group
2019
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| 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 |