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      Abstract submission is now open for RExPO25, the 4th International Conference on Systems Medicine, AI & Drug Repurposing.  Submit your proposal for a talk or poster and join us in Barcelona, Spain, September 24-26, 2025. 

      Deadline for abstracts is June 30, 2025

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      A regulatory roadmap for repurposing: comparing pathways for making repurposed drugs available in the EU, UK, and US

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            Abstract

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            Author and article information

            Journal
            Title: DrugRxiv
            Publisher: REPO4EU
            Publication date (Electronic preprint): 18 November 2024
            Affiliations
            [1 ] departments of IQ health radiology at Radboudumc, Nijmegen, the Netherlands ( https://ror.org/05wg1m734)
            [2 ] department of Clinical Epidemiology & Medical Technology Assessment (KEMTA), Maastricht University Medical Centre, Maastricht, The Netherlands ( https://ror.org/02d9ce178)
            [3 ] Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands ( https://ror.org/02jz4aj89)
            [4 ] Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital/Harvard Medical School, Boston, Massachusetts, USA ( https://ror.org/04b6nzv94)
            [5 ] 3D-PharmXchange, Tilburg, The Netherlands;
            [6 ] Program On Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, MA. ( https://ror.org/04b6nzv94)
            Author notes
            Author information
            https://orcid.org/0000-0003-3102-6011
            Article
            DOI: 10.58647/DRUGARXIV.PR000018.v1
            SO-VID: 6099ceed-48db-443f-b12a-df72c9ffb693
            License:

            This work has been published open access under Creative Commons Attribution License CC BY 4.0 , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Conditions, terms of use and publishing policy can be found at www.scienceopen.com .

            History
            Date received : 18 November 2024
            Funding
            Funded by: funder-id http://dx.doi.org/10.13039/100018696, HORIZON EUROPE Health;
            Award ID: 101057619
            Categories

            Data availability: All data generated or analysed during this study are included in this published article (and its supplementary information files).
            ScienceOpen disciplines: Law
            Keywords: Drug repurposing,prescription drug regulation,European Medicines Agency,US Food and Drug Administration,UK Medicines and Healthcare products Regulatory Agency,drug approvals

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