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Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy

Over the past decades, US Congress enabled the US Food and Drug Administration (FDA) to facilitate and expedite drug development for serious conditions filling unmet medical needs with five special designations and review pathways: orphan, fast track, accelerated approval, priority review, and break...

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Main Authors: Michaeli, Daniel (Author) , Michaeli, Christoph T. (Author) , Albers, Sebastian (Author) , Boch, Tobias (Author) , Michaeli, Julia (Author)
Format: Article (Journal)
Language:English
Published: 2024
In: The European journal of health economics
Year: 2024, Volume: 25, Issue: 6, Pages: 979-997
ISSN:1618-7601
DOI:10.1007/s10198-023-01639-x
Subjects:
Aufsatz in Zeitschrift
Online Access:Verlag, kostenfrei, Volltext: https://link.springer.com/article/10.1007/s10198-023-01639-x
Resolving-System, kostenfrei, Volltext: https://doi.org/10.1007/s10198-023-01639-x
Verlag, kostenfrei: https://link.springer.com/content/pdf/10.1007/s10198-023-01639-x.pdf
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Author Notes:Daniel Tobias Michaeli, Thomas Michaeli, Sebastian Albers, Tobias Boch, Julia Caroline Michaeli

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