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The definition and acceptability of an orphan condition is pivotal for the assessment of European orphan medicinal product designation applications, and consequently the eligibility for incentives. Here, based on the… Click to show full abstract
The definition and acceptability of an orphan condition is pivotal for the assessment of European orphan medicinal product designation applications, and consequently the eligibility for incentives. Here, based on the experiences of the Committee for Orphan Medicinal Products, we discuss how to define orphan conditions in the context of the European regulatory framework.
Keywords:
orphan conditions;
context european;
defining orphan;
conditions context;
european orphan
Journal Title: Nature Reviews Drug Discovery
Year Published: 2019
Link to full text (if available)
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Journal Title: Nature Reviews Drug Discovery
Year Published: 2019
Link to full text (if available)
Share on Social Media: Sign Up to like & get
recommendations!