Recent Changes in U.S. Food and Drug Law: Implications for Drug Development

Abstract

This paper examines in detail the Waxman/Hatch Act and the NDA Rewrite, from both an implementation point of view and from a world-wide research and development perspective. The central theme of these regulatory changes appears to be consistent with U.S. drug policy of the past two decades, i.e., cost containment, primarily, followed by uniformity and efficiency in the regulatory review process. These recent changes, just as the 1962 Drug Ammendments 22 years earlier, will continue to have profound effects upon the sites at which pharmaceutical research and development is carried out.     

U. S. Research assessment: Recent developments

Over the last decade, ex post research assessment at the program level in the United States has seemed much less active than the equivalent activities in Europe, both west and east. This seeming lull was the result of a decline in program evaluation activity across the U.S. government in the 1980s, which slowed the rate of formal evaluations. Program review activities within agencies, however, were common, especially at such mission-oriented research supporting organizations as the Department of Energy and the Office of Naval Research. Review processes at these agencies relied primarily on expert assessment, sometimes at the project level, supplemented by user inputs. Quantitative performance measures were seldom used. That situation is about to change. In 1993, Congress passed the Government Performance and Results Act, which requires all agencies including those support research to set quantitative performance targets and report annually on their progress toward them. Agencies with clear technological goals are rapidly developing sets of indicators for this use, including peer assessments, bibliometric measures including patents, and customer satisfaction ratings. But fundamental research agencies do not find such measures satisfactory, and are just beginning to develop alternative ones.This document represents the views of the author alone and not necessarily those of the National Science Foundation. The author is on leave from the Department of Science and Technology Studies, Rensselaer Polytechnic Institute, Troy, NY 12180-3590.     

美国食品标签管理的细微之处

食品标签制度食品标签作为一种重要的食品安全健康标识,已经在许多国家形成一种重要的认证标识制度,在方便食品安全的监管落实与责任追究的同时,广大消费者也能依据食品标签上的信息,挑选与购买符合安全及健康标准的农产品及食品扑朔迷离的"老酸奶风波"最     

美国食品标签管理的细微之处

食品标签制度 食品标签作为一种重要的食品安全健康标识,已经在许多国家形成一种重要的认证标识制度,在方便食品安全的监管落实与责任追究的同时,广大消费者也能依据食品标签上的信息,挑选与购买符合安全及健康标准的农产品及食品。     

Recent internationalization of global environmental change research in Germany and the U.S.

Summary The possible existence of specialisation patterns by research fields of the Italian regions is investigated. Accordingly, bibliometric data on papers published in international scientific journals have been processed and tailored for regional comparative analysis. The results show that the trends in scientific regional specialisation are related to the research activities performed by each scientific system, but also the regional industrial skill is very often reflected in the corresponding scientific profile. The empirical evidences show also that each Italian region works as a well identifiable scientific system providing for its own specific contribution to the national performance.     

欧美食品包装材料技术法规与标准浅析

本文通过研究分析欧盟、美国的食品包装材料技术法规与标准的现状和我国食品包装材料法规与标准存在的不足,提出了进一步完善我国食品包装材料法规与标准的建议。     

Changes in the U.S. Primary Standards for the Air Kerma From Gamma-Ray Beams

Monte Carlo photon-electron transport calculations have been done to derive new wall corrections for the six NBS-NIST standard graphite-wall, air-ionization cavity chambers that serve as the U.S. national primary standard for air kerma (and exposure) for gamma rays from ⁶⁰Co, ¹³⁷Cs, and ¹⁹²Ir sources. The data developed for and from these calculations have also been used to refine a number of other factors affecting the standards. The largest changes are due to the new wall corrections, and the total changes are +0.87 % to +1.11 % (depending on the chamber) for ⁶⁰Co beams, +0.64 % to +1.07 % (depending on the chamber) for ¹³⁷Cs beams, and −0.06 % for the single chamber used in the measurement of the standardized ¹⁹²Ir source. The primary standards for air kerma will be adjusted in the near future to reflect the changes in factors described in this work.     

美国进口食品进境口岸查验制度简介

美国是我国主要的食品出口国。为了促进我国食品更好地对美国出口,很有必要了解美国的进境口岸查验制度。本文主要介绍了美国食品药品监督管理局(FDA)、食品安全检验局(FSIS)进口食品的进境口岸查验制度,以帮助加强政府监管工作和输美食品顺利通关。     

Comparison of U.S.S.R. Codes and U.S. Army Manual for design of foundations on permafrost

A comparative study was made of design criteria and analytical methods for footings and pile foundations on permafrost employed in U.S.S.R. Design Code SNiP II-18-76 (1977) and U.S. Army Cold Regions Research and Engineering Laboratory Special Report 80-34 developed in the early 1970s by the U.S. Army Corps of Engineers and published in 1980. The absence of adequate constitutive equations for frozen soils and of rigorous solutions of the boundary problems has made it necessary to incorporate (explicitly or implicitly) various safety factors in the foundation analyses. From the review it is concluded that the principal difference between these practices is in the assessment and application of appropriate values of safety factors, which leads to a substantial discrepancy in the dimensions and costs of footings and pile foundations in permafrost.     

美国冷库发展状况研究

美国和我国同属农产品生产和消费大国,其冷库行业起步于19世纪末期,经过100多年的发展,已经形成了覆盖全国的冷链物流体系。冷库作为冷链系统中的主要基础设施,是体现冷链物流发展水平的一项主要指标。本文通过研究分析美国冷库的发展历程,可以对我国冷链物流行业的发展有所借鉴和启示。     

Technological innovation and the U.S. banking industry: Innovation in the U.S. retail and wholesale banking sectors

In this paper, case studies of “best practice” retail and wholesale banks are used to explore the influence of technological change on the banking industry. The impact that specific technologies are having on the retail and whole-sale sectors is discussed. Briefly, the evidence shows that there is tremendous pressure on the banking industry to restructure at the current level of technology and competition. Retail banks are looking to client-server, open systems, groupware, workflow software, and imaging technology to restructure and consolidate their operations. Wholesale banks are using information technology to support specialized fee-income generating strategies. Nonetheless, in both the retail and wholesale banking sectors, nonbank financial service providers such as pension funds, insurance companies, money market funds and mutual funds are gaining market share. As these competitors expand their role, I find that the financial services competitor with the best strategy and technology is increasingly no longer a traditional bank.     

美国为媒体创新广告标准

关于传统媒体广告的价值 媒体就是具有传播信息功能的载体,如电视、报纸、杂志、广播、户外广告牌、互联网等。广告媒体是用于向公众发布广告的传播载体。传统的“四大广告媒体”为电视、电台、报纸和杂志。在广告行业把电视媒体和电台媒体称为电波媒体;把报纸和杂志媒体称为平面媒体。除了传统四大广告媒体外,可供广告发布的媒体还包括户外媒体、互联网媒体和数码媒体等。     

The Quest for Relevance: Roles for Academia and Industry in Japan and the U.S.

While U.S. industry is making headway in worldwide markets, much remains to be done. Some have proposed that improving the relevance of engineering education can have a marked influence on the future success of U.S. manufacturing. Some in academia have heard industries' cries for help to improve relevancy in engineering education and have responded with various solutions. Is this the situation in Japan? What is the state of engineering education in Japan? Where is it headed and how does the U.S. compare? We found that industry-academia relationships like those being strengthened in the U.S. are minimal in Japan. Surprisingly, Japanese industry and academia appear not to be headed in a collaborative direction and are even more detached from one another than in the United States. This paper presents some differences in the way Japan and the U.S. view their roles for academia and industry and their interrelationships. Our objective is to further motivate U.S. educators to collaborate with industry and continue to integrate greater relevancy into engineering education.     

美国船长本职工作标准定位

船长一词来自拉丁语使用旧的罗马帝国时代的Magister Navis，即指定为船上最高权威的贵族（patrizio）。现在船长的英文单词为Captain，另一个是Master或Shipmaster。Captain的意思是“队长、首领、船长、机长、海军上校、陆军上尉、船长”，可见其含义比较多；Master的意思是“主人、雇主、大师、硕士、船长”。英文中有关船长的两个称呼明确显示船长的地位是绝对权威的。事实上，也的确如此。那么，为什么船长是“主人”、“雇主”的意思呢？     

美国《食品危害分析和基于风险的预防控制法规》影响和对策之分析

本文介绍了美国食品危害分析和基于风险的预防性控制（HARPC）新法规的主要内容。该法规旨在建立一套适应未来趋势的食品安全系统,针对所有食品体系实施现代化的基于风险预防的科学控制规范。通过该法规的wTo通报评议,分析其与HACCP的异同和即将带给我国输美出口食品企业的影响和作用,探讨并提出了借鉴和应对的策略建议。