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To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.
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Mirre Scholte
Liam Bendicksen
Sabine Grimm
The Journal of Law Medicine & Ethics
Brigham and Women's Hospital
Radboud University Nijmegen
Maastricht University
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Scholte et al. (Mon,) studied this question.
www.synapsesocial.com/papers/6a008933831589f3542dda0b — DOI: https://doi.org/10.1017/jme.2024.171