《美国食品药品监督管理局现代化法案2.0》：将非动物技术纳入监管范畴。
The FDA modernisation act 2.0: Bringing non-animal technologies to the regulatory table.
作者信息
Stewart Alastair, Denoyer Delphine, Gao Xumei, Toh Yi-Chin
机构信息
ARC Training Centre for Personalised Therapeutics Technologies, Department of Biochemistry and Pharmacology, School of Biomedical Sciences, University of Melbourne, Australia.
ARC Training Centre for Personalised Therapeutics Technologies, Department of Biochemistry and Pharmacology, School of Biomedical Sciences, University of Melbourne, Australia.
出版信息
Drug Discov Today. 2023 Apr;28(4):103496. doi: 10.1016/j.drudis.2023.103496. Epub 2023 Jan 20.
The FDA modernisation Act 2.0 marks a game-changing legislation enabling drug registration without the absolute requirement for the use of animals in safety toxicology assessment. We discuss landmark developments in the legislation under which the FDA operates and consider the implications of this most recent chapter in the evolution of the drug regulation pathway, focussing on new opportunities to embed microphysiological systems.
《美国食品药品监督管理局现代化法案2.0》标志着一项具有变革性的立法，该立法使得在安全毒理学评估中无需绝对要求使用动物即可进行药物注册。我们讨论了美国食品药品监督管理局所依据的立法中的里程碑式进展，并思考了药物监管途径演变中这一最新篇章的影响，重点关注嵌入微生理系统的新机遇。
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