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.     

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.     

关于境内机构捐赠外汇管理有关问题的通知

For the purpose of realizing the adminiswation of donations in foreign exchange and facilitating the receipt and payment of donations in foreign exchange,and pursuant to the Regulations of the People's Republic of China on Foreign Exchange Administration and other relevant laws and regulations, the relevant issues concerning administration of donations in foreign exchange by domestic institutions are hereby promulgated:     

试析行政法领域的思想解放及其走向

新中国行政法是在党的十一届三中全会以后迅速发展起来的。它前行的每一步都凝结着思想解放的成果,它未来的发展亦有赖于思想进一步解放。行政法观念与制度变迁的基本走向是:从管制行政到控权行政再到服务行政,从依政策行政到有法可依再到实质法治,从全能政府到职能转变再到行政组织法治化,从单方强制到刚柔相济再到合作参与,从轻视程序到程序合法再到程序当正,从公权神圣到接受监督再到完善监督、救济制度和建立责任政府等。     

新加坡城市公共管理

2008年12月7日至27日,北京市市政管理委员会组织城市公共基础设施安全与应急管理培训团赴新加坡考察学习.培训过程中,学员们不仅目睹到新加坡经济发展的特色,更切身感受到其绿树葱茏、鲜花盛开的优美环境,和谐有序严明的城市和社会管理,清正廉洁法治的政府运作机制、崇法尚礼的国民素质.     

打造便民绿色通道提升公共服务水平——为民生而设的北京城管热线96310

开通城管热线96310是2001年北京市政府60件为民办实事之一.热线开通以来,市城管执法局按照建设服务型政府的要求,始终贯彻"畅通、高效、务实、为民"的工作理念,坚持"群众利益无小事"的原则,落实"树城管形象,促社会和谐,让市民满意,使领导放心"的工作标准,不断加强城管热线建设,便民绿色通道作用充分发挥,公共服务水平大幅提升.     

突出一个主题 加大六个力度 全面开展“人文奥运法治同行”宣传和实践

举办2008年奥运会是全国人民的共同心愿，是中华民族的百年企盼，开展奥运法制宣传是“五五”普法的重要任务之一，也是法制宣传教育服务经济社会发展中心工作的重要举措。“五五”普法以来，我市紧紧围绕这个中心，突出“人文奥运法治同行”的主题，大力开展奥运法制宣传活动，提高了市民的奥运法律意识，在全市营造了良好的法治氛围，为奥运会的成功举办做出了积极的贡献。