Is the current regulatory framework for direct-to-consumer microbiome-based tests sufficient to protect consumers from medical, economic, and dignitary harms? [0.03%]
现行的直接面向消费者的基于微生物组检测的监管框架是否足以保护消费者免受医疗、经济损失和尊严损害？
Diane E Hoffmann,Felicia D Langel,Erik C von Rosenvinge et al.
Diane E Hoffmann et al.
This article offers a thorough analysis of an important public health issue-the lack of regulation of companies selling direct-to-consumer (DTC) microbiome-based tests. These companies invite curious consumers and desperate patients to subm...
Heritable human genome editing and the politics of law: the South African case study [0.03%]
可遗传的人类基因组编辑与法律政治——南非案例研究
Donrich Thaldar,Sheetal Soni,Larisse Prinsen et al.
Donrich Thaldar et al.
Heritable human genome editing (HHGE) has emerged as one of the most contested frontiers of bioscience, where law is mobilized as a political instrument. This article uses South Africa as a case study in the politics of law in HHGE governan...
The Indian regulatory framework and the surge of unproven stem cell therapies-a call for diagnosis [0.03%]
印度监管框架和未经证实的干细胞疗法的兴起-亟待做出诊断
Vaishnav M
Vaishnav M
Stem cell science lies at the heart of regenerative medicine; it is believed to have the potential to address several otherwise incurable diseases. However, even though stem cell interventions are at the experimental stage, they are adverti...
The future of AI regulation in drug development: a comparative analysis [0.03%]
人工智能在药物开发中的监管趋势：比较分析
Gabriela Lenarczyk,Timo Minssen,Nicholson Price et al.
Gabriela Lenarczyk et al.
As artificial intelligence (AI) transforms drug development, regulatory frameworks are evolving to oversee its implementation, particularly at the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This paper mak...
Clades, classifications, and claims: evolution of organisms and their nomenclature in life science patents [0.03%]
分类与命名：生命科学专利中有机体的进化
Nathan T Jacobs
Nathan T Jacobs
Organisms are complex biological entities that are less easily defined by specific structures or sequences than molecules, nucleic acids, and antibodies. Nor are they necessarily fixed in time or reproducible by repeatable methods, given th...
Ensuring vaccine access through local production: the need for a harmonized and sustainable approach [0.03%]
通过本地生产确保疫苗获取：协调与可持续方法的必要性
Chimdessa Tsega
Chimdessa Tsega
Local vaccine and pharmaceutical production has transitioned from a mere policy option to an essential requirement in the aftermath of the COVID-19 pandemic. Developed countries' vaccine nationalism and hoarding through bilateral agreements...
Reimagining criminal accountability: microbial and omics perspectives in the evolution of legal responsibility [0.03%]
从微生物和组学角度审视刑事归责的演变：重新思考刑事责任问题
Pragya Mishra,Alan C Logan,Susan L Prescott
Pragya Mishra
Recent advances in microbiome science and omics technologies are reshaping our understanding of human behavior, suggesting that microbial communities significantly influence cognition, impulse control, and aggression. Emerging studies in ne...
Cross-border health data sharing between Singapore and Switzerland: controlling for competing regulatory requirements [0.03%]
新加坡与瑞士跨境卫生数据共享：兼顾竞争监管要求
James Scheibner,Hui Yun Chan
James Scheibner
Research in biomedical and health sciences using data-intensive methods increasingly involve multi-party cross-border institutional collaborations. Regulatory complexities governing international data flow remain challenging to navigate, pa...
Partial ectogestation and threats to the fetus: how healthcare professionals' caution may reinforce the medicalization of pregnancy and childbirth [0.03%]
部分外胎盘孕育及对胎儿的威胁：医疗工作者的谨慎态度可能会强化孕期和分娩的医学化现象
Victoria Adkins
Victoria Adkins
Partial ectogestation is being developed in a bid to improve the survival rates and health outcomes associated with prematurity, but limited empirical research has been conducted on the views of key stakeholders, particularly healthcare pro...
A circular bio-economy approach to regulating genetic resource research: rethinking access and benefit sharing [0.03%]
一种循环生物经济的方法来管理基因资源研究：重新思考获取和惠益分享的问题
Fran Humphries
Fran Humphries
Access and benefit sharing (ABS) regulates the collection and use of genetic resources, associated traditional knowledge and in some cases digital sequence information for research and development (R&D) purposes and the equitable sharing of...