From June to July of 2017, the approval rates of the Abe administration fell sharply, in stark contrast to the long-term stability since 2012. The stability of Abe＇ s approval rates originated from the people＇ s neg...From June to July of 2017, the approval rates of the Abe administration fell sharply, in stark contrast to the long-term stability since 2012. The stability of Abe＇ s approval rates originated from the people＇ s negative support for him and their opposition to the Security Laws and other important events as well as the scandals under his administration. The opposition and negative support originated from the people＇s ＂acquired helplessness＂, ＂Abenomics＂, the sharp drop in the opporttmity costs of voting and other conditions. The sudden fall of Abe＇ s approval rates was not due to the change in the aforementioned conditions, rather because of the collapse of his image including personality owing to Abe＇ s perceived arrogance and his estrangement with the people. In the context of the temporary stabilization of approval rates, Abe dissolved the House of Representatives ahead of schedule and held a general election, taking full advantage of the internal strife between the opposition parties, to achieve his goal of ruling until the 2020 Tokyo Olympics. His victory in the recent election does not accurately demonstrate that Abe is completely immune to negative impact, thus he will to use the Korean Peninsula crisis and other issues to demonstrate his ability of safeguarding Japan＇s security, seek reconstruction of his image, and further enhance his approval rate to stabilize his administration.展开更多
FDA是美联邦政府卫生部(DEPARTMENT OF HEALTH AND HUMAN SERVICE简称DHHS直译应为卫生及人类服务部,实即卫生部及有关福利事宜)下的直属机构。是对食品及药物等方面制定规范及进行管理的权威性机关。FDA除主要对食品、药物外还包括有...FDA是美联邦政府卫生部(DEPARTMENT OF HEALTH AND HUMAN SERVICE简称DHHS直译应为卫生及人类服务部,实即卫生部及有关福利事宜)下的直属机构。是对食品及药物等方面制定规范及进行管理的权威性机关。FDA除主要对食品、药物外还包括有生物制品,化妆品及医疗设施等的管理,与农业部(负责肉类、疏菜、水果的管理)、环境保护局(E.P.A)(负责空气、饮水、废弃物、农药、毒品等的管理)分工统管环境中的化学物。它们都是以立法为根据的代表政府的执法机关。 FDA的前身为化学部(DEPARTMENT OF CHEMLSTRY)建于1906年。现有工作人员约8。展开更多
医疗器械唯一标识(unique device identifier,UDI)是医疗器械唯一性识别码,是准确采集医疗器械全生命周期数据的基础,已成为当前医疗器械监管的全球通用语言。2013年9月24日,美国食品药品管理局(Food and Drug Administratio,FDA)发布...医疗器械唯一标识(unique device identifier,UDI)是医疗器械唯一性识别码,是准确采集医疗器械全生命周期数据的基础,已成为当前医疗器械监管的全球通用语言。2013年9月24日,美国食品药品管理局(Food and Drug Administratio,FDA)发布医疗器械唯一标识系统(unique device identification system,UDI system)最终规定并正式实施UDI,为各国以全球协调方式实施UDI提供了经验。本文将系统研究美国UDI发展沿革、法规体系、核心内容与工作进展,对美国UDI实施方案、发码机构、全球UDI数据库(GUDID)及应用情况进行介绍,为我国开展并推进UDI工作提供借鉴和思路。展开更多
为加快创新抗肿瘤药物和医疗器械的审批速度,美国食品药品管理局(Food and Drug Administration,FDA)为肿瘤相关产品的审评成立肿瘤卓越中心。本文通过对肿瘤卓越中心的成立背景、机构设置和工作机制等进行简介,从我国新药审评审批制度...为加快创新抗肿瘤药物和医疗器械的审批速度,美国食品药品管理局(Food and Drug Administration,FDA)为肿瘤相关产品的审评成立肿瘤卓越中心。本文通过对肿瘤卓越中心的成立背景、机构设置和工作机制等进行简介,从我国新药审评审批制度改革的角度提出启示与建议。展开更多
文摘From June to July of 2017, the approval rates of the Abe administration fell sharply, in stark contrast to the long-term stability since 2012. The stability of Abe＇ s approval rates originated from the people＇ s negative support for him and their opposition to the Security Laws and other important events as well as the scandals under his administration. The opposition and negative support originated from the people＇s ＂acquired helplessness＂, ＂Abenomics＂, the sharp drop in the opporttmity costs of voting and other conditions. The sudden fall of Abe＇ s approval rates was not due to the change in the aforementioned conditions, rather because of the collapse of his image including personality owing to Abe＇ s perceived arrogance and his estrangement with the people. In the context of the temporary stabilization of approval rates, Abe dissolved the House of Representatives ahead of schedule and held a general election, taking full advantage of the internal strife between the opposition parties, to achieve his goal of ruling until the 2020 Tokyo Olympics. His victory in the recent election does not accurately demonstrate that Abe is completely immune to negative impact, thus he will to use the Korean Peninsula crisis and other issues to demonstrate his ability of safeguarding Japan＇s security, seek reconstruction of his image, and further enhance his approval rate to stabilize his administration.
文摘FDA是美联邦政府卫生部(DEPARTMENT OF HEALTH AND HUMAN SERVICE简称DHHS直译应为卫生及人类服务部,实即卫生部及有关福利事宜)下的直属机构。是对食品及药物等方面制定规范及进行管理的权威性机关。FDA除主要对食品、药物外还包括有生物制品,化妆品及医疗设施等的管理,与农业部(负责肉类、疏菜、水果的管理)、环境保护局(E.P.A)(负责空气、饮水、废弃物、农药、毒品等的管理)分工统管环境中的化学物。它们都是以立法为根据的代表政府的执法机关。 FDA的前身为化学部(DEPARTMENT OF CHEMLSTRY)建于1906年。现有工作人员约8。
文摘医疗器械唯一标识(unique device identifier,UDI)是医疗器械唯一性识别码,是准确采集医疗器械全生命周期数据的基础,已成为当前医疗器械监管的全球通用语言。2013年9月24日,美国食品药品管理局(Food and Drug Administratio,FDA)发布医疗器械唯一标识系统(unique device identification system,UDI system)最终规定并正式实施UDI,为各国以全球协调方式实施UDI提供了经验。本文将系统研究美国UDI发展沿革、法规体系、核心内容与工作进展,对美国UDI实施方案、发码机构、全球UDI数据库(GUDID)及应用情况进行介绍,为我国开展并推进UDI工作提供借鉴和思路。
