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Defining orphan conditions in the context of the European orphan regulation: challenges and evolution

Item Type:Comment
Title:Defining orphan conditions in the context of the European orphan regulation: challenges and evolution
Creators Name:O'Connor, D.J. and Sheean, M.E. and Hofer, M.P. and Tsigkos, S. and Mariz, S. and Fregonese, L. and Larsson, K. and Hivert, V. and Westermark, K. and Naumann-Winter, F. and Stoyanova-Beninska, V. and Barišić, I. and Capovilla, G. and Magrelli, A. and Sepodes, B.
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.
Source:Nature Reviews Drug Discovery
ISSN:1474-1776
Publisher:Nature Publishing Group (U.K.)
Date:12 September 2018
Official Publication:https://doi.org/10.1038/nrd.2018.128
PubMed:View item in PubMed

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