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

• Asıl Yazarlar: Szymon Jarosławski (Yazar), Pascal Auquier (Yazar), Borislav Borissov (Yazar), Claude Dussart (Yazar), Mondher Toumi (Yazar)
• Materyal Türü: Kitap
• Baskı/Yayın Bilgisi: Taylor & Francis Group, 2018-01-01T00:00:00Z.
• Konular: article
• Online Erişim: Connect to this object online.

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...