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- Title:
Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy
- Document type:
- Zeitschriftenaufsatz
- Author(s):
- Michaeli, Daniel Tobias ; Michaeli, Thomas ; Albers, Sebastian ; Boch, Tobias ; Michaeli, Julia Caroline
- Keywords:
- 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
- Journal title:
- The European Journal of Health Economics
- Year:
- 2023
- Journal volume:
- 25
- Journal issue:
- 6
- Pages contribution:
- 979-997
- Fulltext / DOI:
- doi:10.1007/s10198-023-01639-x
- Publisher:
- Springer Berlin Heidelberg
- E-ISSN:
- 1618-7598 ; 1618-7601
- Date of publication:
- 14.11.2023
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