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Titel:

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

Dokumenttyp:
Zeitschriftenaufsatz
Autor(en):
Michaeli, Daniel Tobias ; Michaeli, Thomas ; Albers, Sebastian ; Boch, Tobias ; Michaeli, Julia Caroline
Stichworte:
Original Paper ; Orphan designation ; Fast track ; Accelerated approval ; Priority review ; Breakthrough therapy ; Clinical trial ; Innovation ; US food and drug administration ; European medicines agency ; Drug development ; Special designation ; Safety ; Efficacy ; Healthcare policy ; Pharmaceutical policy ; Drug price ; I00 ; I1 ; I18 ; I13 ; Economics
Zeitschriftentitel:
The European Journal of Health Economics
Jahr:
2023
Band / Volume:
25
Heft / Issue:
6
Seitenangaben Beitrag:
979-997
Volltext / DOI:
doi:10.1007/s10198-023-01639-x
Verlag / Institution:
Springer Berlin Heidelberg
E-ISSN:
1618-7598 ; 1618-7601
Publikationsdatum:
14.11.2023
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