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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Detalles Bibliográficos
Autores principales: Sheean, Maria E., Naumann-Winter, Frauke, Capovilla, Giuseppe, Kalland, Maria Elisabeth, Malikova, Eva, Mariz, Segundo, Matusevicius, Darius, Nistico, Robert, Schwarzer-Daum, Brigitte, Tsigkos, Stelios, Tzogani, Kyriaki, Larsson, Kristina, Magrelli, Armando, Stoyanova-Beninska, Violeta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8429787/
https://www.ncbi.nlm.nih.gov/pubmed/34513895
http://dx.doi.org/10.3389/fmed.2021.744625

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