Huu S. TIEU Request for FDA to Establish Regenerating Human Cells as Law on December 13, 2016 President Barack H. Obama Signed the 21st Century CURES Act into FDA Regulation and Law

Background and Aims: On November 24, 2009, Huu S. TIEU and Golden Sunrise Pharmaceutical, Inc. (Golden Sunrise) applied for the Technology and Innovation to be reviewed and evaluated by the U.S. Food and Drug Administration (FDA). In the review and evaluation, it was requested by Golden Sunrise designated the new indications for this application under Serious or Life-threatening conditions or diseases. Discussions followed with the FDA, Huu S. TIEU, and Golden Sunrise for FDA approval on new products and new indications on existing new Medical Technology and Innovation. It was agreed in Year-2015 that the FDA would take the request for new indications to the United States Congress to establish into FDA regulation and law. At that time the following was the FDA Guidance—“Emergency Use of a Test Article” is exempt from prior Institutional Review Board or Advisory Committee evaluation and approval, provided that such emergency use is reported to the Institutional Review Board within five working days after use. Expedited Institutional Review Board or Advisory Committee approval is not permitted in emergency use. There has been no funding to the authors for the writing or publication of this article. Methods: It was requested by Huu S. TIEU and Golden Sunrise in documents given to the FDA to have Serious or Life-threatening conditions or diseases indication be recognized by law. On August 08, 2015, the FDA responding to this request took the documentation produced by Golden Sunrise to the United States Congress on behalf of Golden Sunrise and Huu S. TIEU. This article encompasses the FDA regulatory method as well as the discussion and results of the establishment of the FDA and the 21st Century Cures Act. Results: On December 13, 2016, H.R.34—114th United States Congress (2015-2016) 21st Century CURES Act was signed into law by President Barack H. Obama which included the Serious or Life-threatening indication to be written into the CURES Act. In summary, the 21st Century Cures Act is a landmark piece of legislation that enjoyed broad bipartisan support in United States Congress. The main goals of the Act are impactful and should transform future cancer, neurologic, and precision medicine or drug research as well as aid individuals with mental health is intended to facilitate the prompt approval of new agents and devices, clinicians should be aware of the types of data behind an approval and take this into consideration when developing illnesses and opioid dependence. However, some of the wording within the CURES Act regarding the drug and device approval process may bring pause to health care providers including pharmacists. Although this wording and implementing care plans and counseling patients. The 21st Century Cures Act was incorporated into laws and regulations by the FDA under § 3072 of the Act grants the Commissioner of Food and Drugs the authority to appoint and set the annual rate of pay for outstanding and qualified candidates to scientific, technical, or professional positions that support the development, review, and regulation of medical products.

A Review of Native Hawaiian Benefits Received through the Inflation Reduction Act of 2022

On August 16th, 2022, Public Law 117-169, The Inflation Reduction Act of 2022, was signed into law by the President of the United States, Joseph R. Biden Jr. The Inflation Reduction Act of 2022 provides the Native Hawaiian community an opportunity to engage in activities of climate resilience and adaptation through making funds available to support such actions. This article provides a preliminary policy analysis of the Inflation Reduction Act of 2022 to identify the opportunities presented by this legislation that can provide ecological and cultural benefit to the Native Hawaiian community. Findings suggest policy language included in this Act is broad which emphasizes the need for the Senior Program Director of the Office of Native Hawaiian Relations, who is tasked with fund distribution, to rely upon the knowledge of the Native Hawaiian community and ecological experts to direct funds in a manner that best benefits the Native Hawaiian community.

法律行为规范对身份行为的有限适用

身份行为的构造依托于以意思表示为要素的抽象法律行为框架,不能以事实先在性架空意思自治。即使家庭法没有明确规定,身份行为也存在成立和效力的判断问题。根据纯粹身份行为和身份财产行为的区分概括描述适用模式的意义有限,即使是身份财产行为,也不能当然适用法律行为规范,而必须结合具体行为的性质以及所涉法律行为规范之利益状态进行个别化检视。在具体的规范适用检视中,应当首先考虑立法者的法政策决断,然后再考虑不同身份行为的本质。限制法律行为规范的适用往往意味着对当事人意思自治的限制,其背后往往存在维护身份关系安定性及公共利益的特殊考量。

彩礼返还规则司法适用的困境与突破

彩礼是古代婚姻缔结的必经程序,后作为一种民间婚嫁习俗存在已久。近年来,随着天价彩礼的出现以及离婚率的增加,彩礼返还纠纷日益增长,但立法的缺失和现有司法解释的模糊造成了司法实践的困境。通过分析《民法典》实施以来彩礼纠纷高发地区的生效判决文书,发现司法适用中普遍存在着彩礼返还范围不同、彩礼返还比例不一、认定给付人生活困难标准缺位等问题,导致同案异裁现象严重,伤害司法权威。当前,需要从明确彩礼返还范围、建立彩礼返还比例体系、确立给付人生活困难标准三个方面入手,积极建构彩礼返还规则的司法突破路径,让司法为民更加精细化。

智慧图书馆数据开放共享及安全治理平衡研究

数据是智慧图书馆发展过程中必不可少的资源,数据开放共享促进了智慧图书馆数据价值的无限释放,然而也对数据安全治理提出了更高的要求。文章深入剖析欧盟《数据治理法》和《中华人民共和国数据安全法》的内容,合理借鉴两部法律对数据开放共享和安全治理的法律规定及应对策略,结合其法理思想以及智慧图书馆发展实际,从理论指引、数据开放共享架构及数据安全治理保障体系三个维度,提出了适合我国国情的智慧图书馆数据开放共享及安全治理的平衡对策。

我国放生外来入侵物种行为法律规制之现状及完善

我国当前立法已开始重视构建放生外来入侵物种行为的规制制度,与防治外来物种入侵构成“对外+对内”的双重规制保障。然而放生外来入侵物种的法律规制路径在制度设计与解释适用中仍存在禁止放生外来物种范围不明确、惩处机制难以覆盖实际危害后果、公法责任规制选择适用标准模糊、行政主体责任缺失等问题。问题症结源于制度设计的立法分散与标准不一,需要通过加快出台分类分级的外来入侵物种名录、扩充法律规制的修复手段、引入风险评估系数、补充行政机关人员的行政责任等途径加以完善。

大数据时代下数据犯罪行为的刑法规制探索

在迈向大数据时代的过程中,我国面临着网络数据刑法保护机制的现代化挑战。传统刑法在保护网络数据方面显得力不从心,特别是在应对非法获取普通网络数据的行为上,其规制作用明显滞后。鉴于此,大数据背景下,需要依据数据权益的逻辑重新审视非法获取普通网络数据行为的刑事法律规制,确保刑法的立法稳定性与司法解释的适用性,超越以系统安全为中心的单一思维模式,深入挖掘现有罪名的适用潜力。

商业秘密司法保护规则研究

商业秘密民事纠纷中,原告主张保护的信息是否构成商业秘密是案件审理的焦点问题之一,原告所称商业秘密范围的确定及其是否满足秘密性、保密性要件是案件审理的重点。对被诉侵权行为是否成立的评价方面主要有根据证据直接认定和推定两种方式,两种方式均须通过信息比对确定被告获取、披露或使用的信息与涉案商业秘密是否构成相同或实质上相同。被诉侵权行为成立时,须审查被告合法来源抗辩是否成立;确定被告应承担的法律责任时,须根据法律和具体案情确定是否销毁侵权载体、损害赔偿的计算方式,以及是否适用惩罚性赔偿等。若有需要,可对原告主张保护的信息的秘密性和技术信息是否相同或实质上相同等事项进行鉴定。

包装设计中的知识产权风险与应对

为减少包装设计工作中“无意”违法行为的发生。文章基于我国知识产权法律体系,通过总结包装设计经验以及其中知识产权管理的薄弱环节,尝试识别并提出包装装潢、商标、图片、字体中各自潜在的法律风险。针对这些疑难问题从设计师及其管理者视角提出应对建议,旨在为包装设计从业人员提供参考。

“愿望”与“义务”的道德——现实主义视角下伊恩·麦克尤恩《儿童法案》中的法理观

国内对伊恩·麦克尤恩小说伦理维度的研究多以探讨人的心理与情感为主,而对小说现实维度的研究又常常脱离伦理这一聚焦点,仅关注英国社会的历史与政治书写。事实上,麦克尤恩对法律意象及法律主题多层次的关注恰巧能够成为道德伦理与现实社会的联结点。以小说《儿童法案》为例,其从法官菲奥娜这一角色切入,深度演绎法律的内在道德性在立法、司法及自由裁量情境下的局限,以文学“诗性正义”的方式对法律“义务的道德”与“愿望的道德”做出了反思。麦克尤恩从个体描写出发,借由法律视角窥视社会公共道德困境,在揭示作品法理观的同时,也印证了其作品中所蕴含的现实主义诗性伦理。

民法典法律行为违法无效条款的动态系统论解释

《民法典》第一百五十三条第一款中的强制性规定缺乏识别标准,司法解释以效力性和管理性二分的方法构建解释规则又陷入了如何分辨强制性规定的管理性和效力性思维误区,并未探明民事法律行为违法无效的根本原因且法理支撑不足。强制性规定对民事法律行为效力的否定难以在立法或司法解释中事先明定,只有在个案中才能明确。动态系统论以弹性要素修正了概念化的构成要件,为法官的自由裁量提供了空间,回应了强制性规定否定民事法律行为效力的个案判断特点。以动态系统论为指导的违法无效条款解释方案,可以在与法治建设内在互动的社会主义核心价值观这一法律化基本价值场域中提取动态解释要素——以强制性规定规范目的实现的受限程度为首位要素、具体民事利益受法律保护的必要性为次位要素、民事法律行为无效评价的社会效果为后位要素,通过衡量各要素的权重和要素之间补足、对抗的整体效果来判定民事法律行为的效力。对违法无效条款的这一概括性立法予以动态性解释的规范进路由此得以形成,司法裁判的妥当性也通过以自由裁量权为依凭的司法能动性得以实现。

德国法上无效行政行为的认定:理论演进和路径选择

关于无效行政行为的认定,我国行政法学界普遍认可的重大且明显违法标准源自德国法上的明显重大说。除明显重大说,德国法上还存在意思形成说、违法即无效说、个案式利益衡量说、客观重大说等对立见解。借由竞争性观点的批判性检验,重大且明显违法标准可以被不断改进。与之同时,概括规定与列举规定之间存在统一模式和混合模式之辩。我国采取统一模式,而德国原本采用统一模式,但是最终选择混合模式。经分析可知,两种模式各有利弊。统一模式的优点是体系性更强,缺点是难以消除概括规定与列举规定之间的适用冲突。混合模式的优点是实用性更强,缺点是牺牲概括规定与列举规定之间的积极融贯性。通过检讨两种模式的得失,概括规定与列举规定的紧张关系可以得到充分重视。

船舶油污强制清除费用法律性质辨析

明晰船舶油污强制清除费用法律性质是强化船舶油污精准防治机制的应有之义。随着国际船舶油污损害赔偿立法的日臻成熟,我国亟待厘清强制清污费法律性质以完善损害赔偿制度体系。通过批判和继承有关强制清污费法律性质的主流学术观点,沿着认定强制清污行为属于行政强制代履行、识别海事部门与清污第三人订立的协议属于行政协议和明确强制清污费只能由海事部门依公权力向清污义务人求偿这一层层递进的思路展开论述,试图优化强制清污费行政性质认定的论证逻辑。

某ACT验证机纵向DFBW控制律设计

讨论了某ACT验证机纵向数字式电传操纵系统(DFBW)控制律的综合设计方法,概述了具有控制增稳(CAS)、边界(迎角/过载)限制、放宽静稳定性(RSS)补偿和自动配平等功能的纵向DFBW控制律的结构和参数选择,阐明了校正滤波网络的作用和自持振荡的抑制措施。设计结果为试飞所验证。

中国方案:欧盟对数字平台“守门人”监管革新的启示

互联网平台在全球数字经济中的重要性不言而喻,但少数超级平台基于强双边连接性与强数据垄断性的特点,很容易滥用市场权力,成为设置市场进入壁垒的数字平台“守门人”,从而损害消费者权益与公平竞争的市场环境。作为一部专门针对互联网平台的行业立法,欧盟出台的《数字市场法》突破了传统竞争法下的监管框架,其中加强事前监管、对“守门人”施加数据可携带以及互操作义务等监管革新,在一定意义上体现了国际互联网平台监管新趋势。我国未来可适当借鉴欧盟立法经验,加强对互联网平台的事前监管及分类监管,并进一步探索平台数据可携带以及互操作的本土进路。

美国商业秘密法域外适用的扩张与中国应对——以《2022年保护美国知识产权法》为中心

美国商业秘密法的域外适用存在扩张趋势。《2022年保护美国知识产权法》进一步授权美国行政部门对域外商业秘密侵权行为进行制裁,扩大了美国的商业秘密域外执法权,对中国的产业安全和涉外法治建设带来新的挑战。为减少冲突:在政府层面,我国应通过效果标准和适当联系原则构筑中国法的域外适用规则,优化中国反制裁体系的防御和弥补功能,完善多元、开放的金融体制;在市场层面,相关主体应加强海外合规和风险预警机制,积极通过行政复议或司法审查获得救济,主动与法案质疑者、其他被制裁主体和因制裁受到连带损害的美国企业寻求利益联合。

《反外国制裁法》豁免机制的体系构建

《反外国制裁法》的实施面临着国家安全利益和经济产业利益相互冲突的困境,需要通过豁免机制进行利益衡平。豁免机制是成熟制裁与反制裁机制中的固定组成部分,在解决利益冲突问题、健全反制裁立法体系、实现多重政策目标中具有重要作用。我国《反外国制裁法》中该制度规定的缺失,不利于反制措施的有效实施。欧盟、美国制裁与反制裁立法中都包含了豁免机制,我国可参考其制度经验作出符合中国国情的选择,建立、健全具有可操作性的豁免机制,明确豁免的标准、范围和程序规则。如此,才能有效缓解《反外国制裁法》实施中保护与惩罚的冲突对立,实现安全利益与经济利益的平衡。

《反外国制裁法》实施中的执法问题

《反外国制裁法》的有效运行离不开科学、完备的配套实施制度,行政执法是法律实施的关键环节。《反外国制裁法》文本对执法主体、执法程序和执法方式作出了规定,但从实施层面看,仍存在执法机构的职能权限和工作程序不清晰、执法程序有待细化、具体法律责任内容不明确等问题,影响《反外国制裁法》的实施效果。为切实发挥《反外国制裁法》的对外斗争功能,应建立切实有效的反外国制裁工作协调机制,根据实践进一步优化执法程序,细化法律责任规定,以保障执法工作有效开展,更好地回应我国当前反制裁、反干涉和反长臂管辖的战略需求。

The Legally Permissible Traditional Customary Uses of Wildlife and Forests under Kenyan Law

Kenya like most of sub-Saharan Africa is reliant predominantly on agriculture and natural resources;which include land, water, minerals and fisheries, but the most dominant of which are wildlife and forestry. Unlike minerals which are by law vested in the government and can only be extracted by it and not the citizenry, wildlife and forestry are resources that the citizens may utilize in their day to day lives to meet their needs. Apart from their consumptive uses, there are also non-consumptive uses and values of wild animals and forests;such as their intrinsic ecological value as gene banks, as well as their scenic value for viewing. These are essentially conventional values and uses. They are largely formal and universal ones that are universally obtaining across the world irrespective of the levels of civilization or cultural identity, and are even compatible with modernity. Apart from these, there are some wildlife and forestry uses which are unique to the typical African way of life as part of old traditional customs that have existed from earlier times. These are what are in this paper referred to as “traditional customary uses”. These uses are largely informal, rudimentary and archaic. They are nevertheless critical in the endemic African way of life and represent the inextricable rudimentary technologically bereft relationship between the African people and their natural resources. Under the country’s existing laws, some of these uses are prohibited and criminal sanctions prescribed to enforce their proscription, hence cannot be enjoyed or practiced. There are however others that the law has either expressly allowed, or not prohibited, hence may be lawfully enjoyed or practiced. These are what this paper has referred to as the legally permissible traditional customary uses;and are the ones that are its subject. As for wildlife, in the year 1977, the Kenya Government by a Legal Notice in the Kenya Gazette imposed a ban on all forms of hunting of wildlife. The ban is still in force. This therefore means that hunting is illegal, as legal prohibition has in effect prohibited all and any form of off-take or killing of wildlife. By implication therefore, under Kenyan law, only non-consumptive uses of wildlife may be enjoyed, and not the consumptive ones. These include viewing as well as socio-cultural and spiritual uses. In Kenya therefore, the only permissible traditional customary use of wildlife is its non-consumptive use for socio-cultural and spiritual purposes;subject of course to the existing legal prohibition on witchcraft under the Witchcraft Act (Cap 67 Laws of Kenya). This piece of legislation has prohibited the practice and promotion of witchcraft. This in effect means that the socio-cultural and spiritual uses of wildlife though legally permissible, will be enjoyed, provided it is not for witchcraft purposes. With regard to forests, this author has identified the following five as their legally permissible traditional customary uses under Kenyan law: Socio-cultural and spiritual (consumptive and non-consumptive) use, other than for witchcraft;use in herbal folk medicine, other than for witchcraft;use for human food and livestock fodder;use for firewood;and use as raw material in construction and traditional craft. Notably, in Kenya, traditional customary use is subject to the existing legal prohibition on witchcraft. Further, while it is the legally permissible use category that is the focus of this paper, the author nevertheless discusses the prohibited traditional customary uses as well. This paper is based on literature survey as well as data obtained from the author’s previous research whose primary data and findings have been published in recent times. It also draws from the documented research and diverse documented views of other commentators on the subject.

股权让与担保组织法效果的省思与重塑——以股权登记为规范理路

股权让与担保融资法律结构中出现当事人内心真意与外观公示信息不一致的效果,致使受让股权的债权人身份存在组织法认定上的疑难。当争议发生在股东与债权人之间时,可依担保合同或可推知意思表示径行解决,但一旦引入外部第三人视角,同时考虑公司人格独立存在的客观现实,如不准确厘定担保债权人因股权转让登记所形成的法律身份,将导致原股东、担保债权人、公司及以上主体各自的债权人与债务人陷入信赖利益受损风险。当前的穿透认定规则忽视了交易安全,凸显组织强制与合同自治之间的联动不足,应通过股权登记的优化消解“形式与实质”区分、“合同与公司”分离等分析理路的困境。在保护商事交易效率性和安全性的规范目的指引下,可借助动产与权利统一登记体系引入、工商登记补充以及信托登记建构三种方案完善股权让与担保公示机制,纾解股权让与担保中的组织法困境。