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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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Podrobná bibliografie
Vydáno v:BMJ Open
Hlavní autoři: Vokinger, Kerstin Noëlle, Kesselheim, Aaron S
Médium: Artigo
Jazyk:Inglês
Vydáno: BMJ Publishing Group 2019
Témata:
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC6797305/
https://ncbi.nlm.nih.gov/pubmed/31601584
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1136/bmjopen-2018-028634
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