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171.
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. 相似文献
172.
Gavazzi SM Yarcheck CM Rhine EE Partridge CR 《International journal of offender therapy and comparative criminology》2003,47(3):291-308
Responding to a model of juvenile offender case supervision that called for a new intervention paradigm to guide the work of probation and parole officers, the present article reports on the use of a family-based parole initiative known as the Growing Up FAST program. Developed in part as a tool for use within this new intervention paradigm, the Growing Up FAST parole program targets serious youthful offenders who have been released from juvenile correctional facilities and their families. Based on elements contained within the "what works" literature and the Balanced and Restorative Justice model, this program recognizes the central role that field staff can play in rehabilitation efforts. Demographic information and formative data regarding the first set of families to participate in this program are presented, then program limitations and lessons learned as part of the initial offering of this parole initiative are discussed. 相似文献
173.
174.
Nahid Aslanbeigui Steven Pressman Gale Summerfield 《International Journal of Politics, Culture, and Society》2003,16(3):483-487
Biography
About the Authors 相似文献175.
Introduction
Introduction to special issue on professional insecurities 相似文献176.
Commentary
Commentaries on Brunner and Willards professional insecurities 相似文献177.
中心城市突破是实施延边州经济跨越式发展战略和实现延边“兴边富民行动”的客观要求。延边中心城市现代化战略目标的顺利完成必须从延边实际出发,制定并组织实施与延边经济社会发展全局有关的一些重大的发展战略。 相似文献
178.
国有资产管理体制和运行机制研究课题组 《陕西行政学院学报》2003,17(4)
陕西国有资产管理体制构想:统一归属,分类监管;党政一体,“三管”结合;政企分开,三层营运;属地纳税,收益分流。资本运营应规范和有效控制授权监督机制、“三管”结合机制、业积考核与评价机制。 相似文献
179.
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. 相似文献
180.
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. 相似文献