Patient-reported outcome claims in European and United States orphan drug approvals

Purpose: We aimed to evaluate the rate of usage and the kind of patient-reported outcome (PRO) claims in orphan drug approvals from the European Medicines Agency (EMA) dated between 1/1/2012 and 31/12/2016 and to compare them to those from the US Food and Drug Administration (FDA). Methods: Orphan d...

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Detalles Bibliográficos
Autores principales: Jarosławski, Szymon, Auquier, Pascal, Borissov, Borislav, Dussart, Claude, Toumi, Mondher
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Routledge 2018
Materias:
Original Research Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6225506/
https://www.ncbi.nlm.nih.gov/pubmed/30425804
http://dx.doi.org/10.1080/20016689.2018.1542920

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6225506/
https://www.ncbi.nlm.nih.gov/pubmed/30425804
http://dx.doi.org/10.1080/20016689.2018.1542920

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