International Conference on Harmonisation; Guidance on E15 Pharmacogenomics Definitions and Sample Coding; Availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories." 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 contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the ICH. The guidance is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.     

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Residue on Ignition/Sulphated Ash General Chapter; Availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on Ignition/Sulphated Ash General Chapter.' 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 the results of the ICH Q4B evaluation of the Residue on Ignition/Sulphated Ash General Chapter harmonized text from each of the three pharmacopeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability among these texts from the local regional pharmacopeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."     

Patient safety and quality improvement. Notice of proposed rulemaking

This document proposes regulations to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The proposed regulations establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for analysis of patient safety events. The proposed regulations also outline the requirements that entities must meet to become PSOs and the processes for the Secretary to review and accept certifications and to list PSOs. In addition, the proposed regulation establishes the confidentiality protections for the information that is assembled and developed by providers and PSOs, termed "Patient safety work product" by the Patient Safety Act, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.     

Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.     

Updating OSHA standards based on national consensus standards. final rule; confirmation of effective date

OSHA is confirming the effective date of its direct final rule that revises a number of standards for general industry that refer to national consensus standards. The direct final rule states that it would become effective on March 13, 2008 unless OSHA receives significant adverse comment on these revisions by January 14, 2008. OSHA received no adverse comments by that date and, therefore, is confirming that the rule will become effective on March 13, 2008.     

期货交易的若干法律问题

<正> 期货交易是商品经济高度发展的必然产物,其特有的套期保值功能、防止市场过度波动功能、节约商品流通费用功能以及促进公平竞争功能对于发展我国目前日益活跃的商品流通体制具有重要意义。近年来,我国的期货交易有了很大的发展,但是由于缺乏相应的立法,各地各行其事,使得期货交易处于无法可依的状态,且过度投机行为盛行。目前,加强期货交易的专门立法极为必要。本文意图对期货交易的若干法律问题进行探讨,以供立法者参考。 一、期货交易的法律性质问题     

对依法治国与以德治国的哲学思考

法治是德治的升华,德治是法治的思想前提,法治与德治相结合是社会主义市场经济的内在要求。     

浅谈延边民营经济发展现状及发展方向

大力发展民营经济,是延边推进跨越式发展、实现富民强州目标确立的重要战略之一,要重点抓好抓实。     

以"三个代表"思想为指导积极推进非公有制经济组织的党建工作——浙江乐清市非公有制经济组织党建实践的调查与思考

改革开放二十多年来,特别是1992年邓小平南方谈话以后,非公有制经济得到了迅速发展.如何在非公有制经济组织中建立和发展党组织,既充分实现和发挥党组织对非公有制经济组织及其业主的领导作用,又促进非公有制经济的健康发展,这是党建工作面临的新课题.中共浙江乐清市委解放思想,实事求是,在实践中进行大胆探索和创新,并积累了初步成功的实践经验.