Artikkelit - Selaus asiasanan mukaan "EMA"
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A Comparative Review of Marketing Authorization Decisions in Switzerland, the EU, and the USA
Therapeutic Innovation and Regulatory Science (SAGE Publications Inc., 19.04.2018) -
Are products with an orphan designation for oncology indications different from products for other rare indications? : A retrospective analysis of European orphan designations granted between 2002-2012
Orphannet Journal of Rare Disease : 1 (BioMed Central, 16.02.2017)Background: Orphan designated medicinal products benefit from regulatory and economic incentives for orphan drug development. Approximately 40% of orphan designations target rare neoplastic disorders, referring to rare ...