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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Detalles Bibliográficos
Autores principales: Tsigkos, Stelios, Mariz, Segundo, Llinares, Jordi, Fregonese, Laura, Aarum, Stiina, Frauke, Naumann-Winter, Westermark, Kerstin, Sepodes, Bruno
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Review
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264401/
https://www.ncbi.nlm.nih.gov/pubmed/25475155
http://dx.doi.org/10.1186/s13023-014-0175-8

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264401/
https://www.ncbi.nlm.nih.gov/pubmed/25475155
http://dx.doi.org/10.1186/s13023-014-0175-8

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