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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...
保存先:
| 出版年: | Orphanet J Rare Dis |
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| 主要な著者: | , , , , , , , |
| フォーマット: | Artigo |
| 言語: | Inglês |
| 出版事項: |
BioMed Central
2014
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| 主題: | |
| オンライン･アクセス: | 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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