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Defining orphan conditions in the context of the European orphan regulation: challenges and evolution.
Nature Reviews. Drug Discovery 2018 September 13
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.
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