Ingrown toenail relief drug products for over-the-counter human use. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing conditions under which over-the-counter (OTC) ingrown toenail relief drug products containing sodium sulfide 1 percent in a gel vehicle are generally recognized as safe and effective and not misbranded. This rule also amends the regulation that lists nonmonograph active ingredients in OTC drug products for ingrown toenail relief by removing sodium sulfide from that list. This final rule is part of FDA's ongoing review of OTC drug products.     

Labeling for oral and rectal over-the-counter drug products containing aspirin and nonaspirin salicylates; Reye's Syndrome warning. Final rule

The Food and Drug Administration (FDA) is issuing a final rule to amend its regulations to revise the Reye's syndrome warning required for oral and rectal over-the-counter (OTC) human drug products containing aspirin and to require a warning on OTC drug products containing nonaspirin salicylates as active ingredients. The revised warning will inform consumers of the symptoms of Reye's syndrome and advise that aspirin and nonaspirin salicylate drug products should not be given to children or teenagers who have or are recovering from chicken pox or flu-like symptoms. This final rule also finalizes FDA's notice of proposed rulemaking to require a Reye's syndrome warning for orally administered OTC drug products for relief of symptoms associated with overindulgence in food and drink (overindulgence drug products) that contain bismuth subsalicylate that published in the Federal Register of May 5, 1993 (58 FR 26886). FDA is issuing this final rule after considering public comment on the agency's notices of proposed rulemaking and all relevant data and information that have come to the agency's attention.     

Food labeling: health claims; soluble dietary fiber from certain foods and coronary heart disease. Final rule

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on the relationship between beta-glucan soluble fiber from whole oat sources and reduced risk of coronary heart disease (CHD). FDA is taking this action to complete the rulemaking initiated with the interim final rule.     

International Conference on Harmonisation; guidance on electronic common technical document specification; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M2 eCTD: Electronic Common Technical Document Specification." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance defines the means for industry-to-agency transfer of regulatory information that will facilitate the creation, review, life cycle management, and archiving of the electronic submission. The guidance is intended to assist industry in transferring electronically their marketing applications for human drug and biological products to a regulatory authority.     

“两个先锋队”思想是对马克思主义政党性质学说的继承和发展

"两个先锋队"思想是对马克思主义政党性质学说的继承和发展.其继承体现为:坚持了基本原则;继承了动态发展观;是历史经验的科学总结.其发展表现在:新的概括表述;历史经验的新启发;解决了历史性课题;突破了传统框框.文中还从指导思想和价值取向、实践"三个代表"、加强党的自身建设三个方面陈述了在新世纪里如何当好"两个先锋队"问题.     

International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products." The revised guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance sets forth recommendations on the information to be submitted in the stability data package for a new drug substance or drug product for a registration application within the three regions of the European Union (EU), Japan, and the United States. The purpose of there vision is to add information to certain sections and to provide clarification to other sections of the guidance.     

International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance provides a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.     

论胫骨——身高的切比雪夫曲线拟合

本文主要通过对胫骨长度的统计,应用切比雪夫曲线拟合方法,结合计算机进行程序设计,从而求出胫骨与身高之间的多项关系式.     

监禁死亡的法医病理学研究

目的　探讨监禁死亡的法医病理学及其流行病学特点。方法　对华西医科大学法医学系 1 987～ 1 998年所作 5 2例监禁死亡案例病理材料进行统计分析。结果　性别 :5 2例均为男性。年龄 :从 1 8岁～ 70岁 ,以 2 1至 4 0年龄段为主 ( 6 1 5 3% )。民族 :汉族人居多 ( 84 6 1 % )。职业 :待业、农民、工人最多 ( 75 % )。婚姻状态 :已婚者占多数 ( 5 9 6 1 % )。监禁原因 :以抢劫、偷盗为主 ( 6 3 4 6 % ) ,首次被监禁为主 ( 94 2 3% )。监禁死亡时间以 3个月常见 ( 36 5 4 % ) ,死亡地点以派出所、看守所及监狱常见 ( 82 6 9% )。死亡方式 :自然死亡以肺结核及支气管炎为主 ( 4 6 1 5 % ) ,自杀以自缢及高坠为主 ( 4 8 1 5 % ) ,少部分为他杀 ,以同监犯人打死为主( 5 76 % )。结论　监禁中死亡与多种因素有关 ,防止该类事件的发生需要各方面的努力。     

论WTO法下的中国法制变化

中国入世后在WTO法的约束下,较快地完成了将WTO法转化为大量国内法的艰巨任务。中国入世所引起的国内法制的直接变化和法治观念的间接变化,不亚于30多年前中国法制的重建。WTO法所包括的协定尚无具有国际法效力的中文本,对于国内实施带来诸多困难,但是,中国依然通过对应式、归纳式和分散式三种国内立法转化WTO法而履行了实施义务,并由此促进了中国法制透明度的增强与法治观念的变化。诚然,就国际法与国内法的关系而言,为了进一步适应WTO法,中国《宪法》的缔约规定亟待修改,WTO法在国内的司法解释应予进一步规范,立法解释与司法解释的关系应予理顺。