Exploring the Potential Challenges for Developing Generic Orphan Drugs for Rare Diseases: A Survey of US and European Markets

The US Food and Drug Administration in 1983 and the European Union’s European Medicines Agency in 2000 implemented the orphan drug development program for rare diseases. The study aimed to find the potential challenges encountered by generic companies in developing generics for rare diseases. We per...

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Veröffentlicht in:	Value in health regional issues 2023-05, Vol.35, p.87-94
Hauptverfasser:	Murthannagari, Vivek Reddy, Gonna Nandhi Krishnan, Ganesh, Manu, Kavitha Viswabramhana, Jayachandraiah, Chandu Thoti, Mandadhi Rajendra, Praharsh Kumar, Ahmed, Syed Suhaib
Format:	Artikel
Sprache:	eng
Schlagworte:	Child Drug Approval Drugs, Generic - therapeutic use European Union’s European Medicines Agency generic orphan drugs Humans Orphan Drug Production rare diseases Rare Diseases - drug therapy United States United States Food and Drug Administration US Food and Drug Administration
Online-Zugang:	Volltext
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