Accelerated drug approval: Meeting the ethical yardstick

Drugs addressing unmet medical needs can change the lives of millions. Developing and validating new drugs can, however, take many years. To streamline the assessment of new drugs, regulatory agencies have long established shortened review pathways. Among these programs, Accelerated Approval (AA) ha...

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Bibliographic Details
Authors: Andreoletti, Mattia (Author) ; Blasimme, Alessandro (Author)
Format: Electronic Article
Language:English
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Published: Wiley-Blackwell 2023
In: Bioethics
Year: 2023, Volume: 37, Issue: 7, Pages: 647-655
IxTheo Classification:KBQ North America
NCH Medical ethics
NCJ Ethics of science
XA Law
Further subjects:B drug regulation
B Aducanumab
B Accelerated Approval
B ethics of clinical research
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