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.     

Medicare program; changes to the hospital inpatient prospective payment systems and fiscal year 2004 rates. Final rule

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital costs to implement changes arising from our continuing experience with these systems. In addition, in the Addendum to this final rule, we are describing changes to the amounts and factors used to determine the rates for Medicare hospital inpatient services for operating costs and capital-related costs. These changes are applicable to discharges occurring on or after October 1, 2003. We also are setting forth rate-of-increase limits as well as policy changes for hospitals and hospital units excluded from the IPPS that are paid on a cost basis subject to these limits. Among other changes that we are making are: changes to the classification of cases to the diagnosis-related groups (DRGS); changes to the long-term care (LTC)-DRGs and relative weights; the introduction of updated wage data used to compute the wage index; the approval of new technologies for add-on payments; changes to the policies governing postacute care transfers; payments to hospitals for the direct and indirect costs of graduate medical education; pass-through payments for nursing and allied health education programs; determination of hospital beds and patient days for payment adjustment purposes; and payments to critical access hospitals (CAHs).     

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.     

Medicare,Medicaid, and CLIA programs; laboratory requirements relating to quality systems and certain personnel qualifications. Final rule

This final rule revises and responds to comments on certain laboratory requirements issued pursuant to the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Pub. L. 100-578. Specifically, this final rule sets forth requirements for certain quality control (QC) provisions and personnel qualifications; consolidates and reorganizes the requirements for patient test management, QC, and quality assurance; and changes the consensus required for grading proficiency testing challenges. To ensure a smooth transition to the new provisions for directors of high complexity testing who are not board certified (but who have doctoral degrees), we will not be holding facilities out of compliance with the provisions of the rule concerning directors who are not board certified until the effective date of this new rule, to the extent the facilities are otherwise in compliance with the requirements for laboratory directors.     

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.     

苏联法影响中国法制发展进程之回顾

在 2 0世纪中国历史上 ,苏联的革命法制理论和若干重要制度曾深刻地影响了中国的法制发展进程。孙中山曾主张“以俄为师”并进行过法制改革 ;中国共产党所领导下的人民民主政权的法制建设也是以苏联为标尺 ;新中国成立初期在创立社会主义法制的过程中 ,更是将苏联法全方位地移植到了中国。苏联法制为中国革命政党所接受与其自身的性质和中国革命的需要紧密相关。     

中国传统法研究中的几个问题

一个多世纪以来 ,传统法在中国常常被视为法治的绊脚石而受到责难。这种旷日持久的责难形成了种种偏见。比如在中西法的比较中习惯以西方法的理论、模式为标准来割裂传统法的有机组成 ;在论述传统法内容时局限于刑 ,而基本排斥了最具特色的“礼” ;过分强调法发展的一般规律 ,而忽视了不同文化背景下法所具有的特殊性。因此 ,在批判传统法的同时 ,我们需要反省对传统法的态度、反省研究中所持的标准、反省研究的方法 ,以求更准确、更合理地解读中国传统法     

About the Authors

Biography

About the Authors     

Introduction to special issue on ‘professional insecurities’

Introduction

Introduction to special issue on professional insecurities