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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Bibliographic Details
Published in:Orphanet J Rare Dis
Main Authors: Tsigkos, Stelios, Mariz, Segundo, Llinares, Jordi, Fregonese, Laura, Aarum, Stiina, Frauke, Naumann-Winter, Westermark, Kerstin, Sepodes, Bruno
Format: Artigo
Language:Inglês
Published: BioMed Central 2014
Subjects:
Review
Online Access: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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