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European priority review vouchers for neglected disease product development.欧洲优先审评券,用于治疗被忽视疾病的药物研发。
BMJ Glob Health. 2024 Jan 30;9(1):e013686. doi: 10.1136/bmjgh-2023-013686.
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Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy.药物研发的特殊 FDA 认定:孤儿药、快速通道、加速批准、优先审评和突破性疗法。
Eur J Health Econ. 2024 Aug;25(6):979-997. doi: 10.1007/s10198-023-01639-x. Epub 2023 Nov 14.
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From private incentives to public health need: rethinking research and development for pandemic preparedness.从私人激励到公共卫生需求:重新思考大流行防范的研发工作。
Lancet Glob Health. 2023 Oct;11(10):e1658-e1666. doi: 10.1016/S2214-109X(23)00328-5. Epub 2023 Aug 28.
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Breakthrough treatments for Ebola virus disease, but no access-what went wrong, and how can we do better?埃博拉病毒病的突破性疗法,但无法获得——出了什么问题,我们如何才能做得更好?
Lancet Infect Dis. 2023 Jul;23(7):e253-e258. doi: 10.1016/S1473-3099(22)00810-6. Epub 2023 Jan 19.
6
The Impact of the Priority Review Voucher on Research and Development for Tropical Diseases.优先审评券对热带病研究与开发的影响。
Pharmaceut Med. 2022 Jun;36(3):189-197. doi: 10.1007/s40290-022-00427-x. Epub 2022 May 19.
7
European governments should align medicines pricing practices with global transparency norms and legal principles.欧洲各国政府应使药品定价做法符合全球透明度规范和法律原则。
Lancet Reg Health Eur. 2022 Apr 21;16:100375. doi: 10.1016/j.lanepe.2022.100375. eCollection 2022 May.
8
Reboot biomedical R&D in the global public interest.为了全球公共利益重启生物医学研发。
Nature. 2022 Feb;602(7896):207-210. doi: 10.1038/d41586-022-00324-y.
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Priority Review Vouchers: GAO Report Provides Scant Evidence of Success.优先审评券:政府问责局的报告几乎没有提供成功的证据。
Clin Transl Sci. 2021 Jan;14(1):8-10. doi: 10.1111/cts.12878. Epub 2020 Sep 19.
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Public investments in the clinical development of bedaquiline.对贝达喹啉临床开发的公共投资。
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The priority review voucher: a misconceived quid pro quo.

作者信息

Olliaro Piero, Torreele Els

机构信息

ISARIC, Pandemic Sciences Institute, Nufflield Departmente of Medicine, University of Oxford, Oxford, UK

Independent Researcher, Geneva, Switzerland.

出版信息

BMJ Glob Health. 2024 Dec 3;9(12):e015933. doi: 10.1136/bmjgh-2024-015933.

DOI:10.1136/bmjgh-2024-015933
PMID:39631790
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11624706/
Abstract
摘要