Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit–The EU Regulator's Perspective

Since the implementation of the EU Orphan Regulation in 2000, the Committee for Orphan Medicinal Products at the European Medicines Agency has been evaluating the benefits of proposed orphan medicines vs. satisfactory treatment methods. This type of evaluation is foreseen in the Orphan Regulation as...

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Auteurs principaux:	Maria E. Sheean, Frauke Naumann-Winter, Giuseppe Capovilla, Maria Elisabeth Kalland, Eva Malikova, Segundo Mariz, Darius Matusevicius, Robert Nistico, Brigitte Schwarzer-Daum, Stelios Tsigkos, Kyriaki Tzogani, Kristina Larsson, Armando Magrelli, Violeta Stoyanova-Beninska
Format:	Artigo
Langue:	Inglês
Publié:	Frontiers Media S.A. 2021-08-01
Collection:	Frontiers in Medicine
Sujets:	orphan designation satisfactory methods of treatment significant benefit orphan regulation committee for orphan medicinal products
Accès en ligne:	https://www.frontiersin.org/articles/10.3389/fmed.2021.744625/full
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