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Establishing medical plausibility in the context of orphan medicines designation in the European Union

In the European Union, sponsors have the responsibility to demonstrate the “intention to diagnose, prevent or treat” a serious and rare condition before the Committee of Orphan Medicinal Products (COMP), for a medicinal product to meet the criteria for Orphan Designation. This requirement is commonl...

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Podrobná bibliografie
Vydáno v:Orphanet J Rare Dis
Hlavní autoři: Tsigkos, Stelios, Mariz, Segundo, Llinares, Jordi, Fregonese, Laura, Aarum, Stiina, Frauke, Naumann-Winter, Westermark, Kerstin, Sepodes, Bruno
Médium: Artigo
Jazyk:Inglês
Vydáno: BioMed Central 2014
Témata:
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC4264401/
https://ncbi.nlm.nih.gov/pubmed/25475155
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13023-014-0175-8
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