Profiles of Regulatory Agencies of the United States and Canada
Author :
Publisher :
Page : 546 pages
File Size : 28,98 MB
Release : 1993
Category :
ISBN :
Author :
Publisher :
Page : 546 pages
File Size : 28,98 MB
Release : 1993
Category :
ISBN :
Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
Page : 169 pages
File Size : 46,42 MB
Release : 2020-04-25
Category : Medical
ISBN : 0309498635
Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today's world, what policy makers need to know about today's regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.
Author : Institute of Medicine
Publisher : National Academies Press
Page : 347 pages
File Size : 12,71 MB
Release : 2007-03-27
Category : Medical
ISBN : 0309103045
In the wake of publicity and congressional attention to drug safety issues, the Food and Drug Administration (FDA) requested the Institute of Medicine assess the drug safety system. The committee reported that a lack of clear regulatory authority, chronic underfunding, organizational problems, and a scarcity of post-approval data about drugs' risks and benefits have hampered the FDA's ability to evaluate and address the safety of prescription drugs after they have reached the market. Noting that resources and therefore efforts to monitor medications' riskâ€"benefit profiles taper off after approval, The Future of Drug Safety offers a broad set of recommendations to ensure that consideration of safety extends from before product approval through the entire time the product is marketed and used.
Author : James K. Bracken
Publisher : Routledge
Page : 255 pages
File Size : 21,13 MB
Release : 2021-12-16
Category : Language Arts & Disciplines
ISBN : 1000149145
As the telecommunication and information field expands and becomes more varied, so do publications about these technologies and industries. This book is a first attempt to provide a general guide to that wealth of English-language publications -- both books and periodicals -- on all aspects of telecommunication. It is a comprehensive, evaluative sourcebook for telecommunications research in the United States that brings together a topically-arranged, cross-referenced, and indexed volume in one place. The information provided is only available by consulting a succession of different directories, guides, bibliographies, yearbooks, and other resources. On the one hand, it is a directory that describes in detail the major entities that comprise the American telecommunication research infrastructure including federal and state government offices and agencies, and private, public, and corporate research institutions. On the other hand, it is a bibliography that identifies and assesses the most important and useful reference and critical resources about U.S. telecommunication history, technology, industry and economics, social applications and impacts, plus policy, law and regulations, and role in the global telecommunication marketplace. No existing guide covers all of these aspects in the depth and detail of this volume.
Author :
Publisher :
Page : 1536 pages
File Size : 24,45 MB
Release : 1993
Category : Periodicals
ISBN :
A union list of serials commencing publication after Dec. 31, 1949.
Author : Bradly J. Condon
Publisher : Kluwer Law International B.V.
Page : 250 pages
File Size : 29,22 MB
Release : 2003-01-01
Category : Law
ISBN : 9041122265
The intersection of insurance regulation and trade agreements is of obvious significance to international competitiveness and, thereby, to national welfare. Yet until this masterful study the subject has remained virtually unexplored. Insurance Regulation in North America, far from merely addressing this important area of theory and practice, superbly balances a world of detailed analysis and commentary with deeply insightful interpretation and debate. The book's focus on insurance regulation in three countries allows the authors to approach the subject in an extraordinary depth that could not be achieved in a more global account. In the course of their treatment the authors offer the reader the following invaluable insights, among many others:analysis of the political dimension of reaching agreements and of implementing them;comparison of the three major trade agreements that apply in the North American insurance market'NAFTA, WTO agreements on financial services, and MEUFTA (the Mexico-European Union Free Trade Agreement)'with emphasis on the relationship between GATS and NAFTA principles;investigation of the clear convergence of regulatory schemes and the probable limits to harmonization;discussion of the arbitrage by which companies get around regulatory restrictions and exploit opportunities created by loopholes;clarification of the crucial issues surrounding the role of customary international law principles in investor protection obligations;discussion of the level of government and which government agencies a company must turn to in order to satisfy legal requirements;analysis of the jurisprudence of the Supreme Court of Mexico regarding legal effects of treaties on domestic law;commentary on the effects of demutualization and of mergers and acquisitions;discussion of the effect of the entrenchment of U.S. State regulations and the federal government's lack of clear power to force State compliance; anddescription of dispute settlement procedures between governments. Although important issues arising in each of the three countries are all covered, there is an emphasis on the Mexican market in recognition of Mexico's greater future growth potential and of the relative paucity of relevant literature in English. Major case studies that reveal processes of compliance or conflict are analyzed in detail. For insurance professionals'lawyers, business executives, and policymakers'who want to understand what international trade agreements contain, how they work, and how they affect domestic insurance regulation and business strategy in what is rapidly becoming a global market for insurance and other financial services, this book is a gold mine. Scholars and academics in insurance law and international economic law will also find here a fresh new treatise of great significance.
Author :
Publisher :
Page : 986 pages
File Size : 34,43 MB
Release : 1994
Category : Statistics
ISBN :
Author : Linda Herkenhoff
Publisher : Business Expert Press
Page : 144 pages
File Size : 40,67 MB
Release : 2018-04-16
Category : Business & Economics
ISBN : 1631579029
We know that the people of Mesopotamia were using crude oil as a tar for building ships and houses as early as 3000 BC, so it is not by any means a new industry-but it is a volatile one. Oil and gas are important to every aspect of our economy yet this industry is distinguished by its combination of increasing demands and decreasing discovery volumes-and it is an industry shrouded in an environment of extremely volatile pricing. This book is a vital introduction to the oil and gas industry that focuses on history, operations, major companies, outside market forces, regulation, and the current challenges the industry faces. Such factors as finite natural resources, the environment, economics, geopolitics, and technology are also analyzed in detail. The focus on oil and gas is likely to continue to grow until efficient, environmentally safe alternate fuels become available. And because it's woven with complex relationships that are ever changing, this book is the best tool to have for a better understanding of this industry.
Author : Institute of Medicine and National Research Council
Publisher : National Academies Press
Page : 208 pages
File Size : 29,58 MB
Release : 1998-08-19
Category : Medical
ISBN : 0309173973
How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.
Author : Linda Herkenhoff
Publisher : Business Expert Press
Page : 101 pages
File Size : 25,26 MB
Release : 2013-11-30
Category : Business & Economics
ISBN : 1606495011
Oil and gas are important to every aspect of our economy, yet the oil and gas industry is distinguished by its combination of increasing demands and decreasing discovery volumes--and it is an industry shrouded in an environment of extremely volatile pricing. Although the profits enjoyed by the oil and gas industry are enormous, the industry remains one of the most capital-intensive in a world where rising expenses continue to threaten to squeeze profit margins. Geopolitics may continue to be the most important variable in maintaining existing assets and in successfully achieving new discoveries and carrying out their subsequent development. But finding new oil and gas reserves is becoming more challenging and the places where hydrocarbons are being found are more remote. Thus technology advances are also a key variable to enable exploration, drilling and development to become economically feasible in some of these more difficult operating environments. For the last century oil and gas additions have exceeded demand but has this industry now reached a "peak oil" situation? Some experts argue we are on the cusp of maximum oil production while others suggest we are still about a decade away. Natural gas demand however, is rising at a slightly faster rate than oil. Natural gas may be the immediate replacement fuel for oil as a source of clean and efficient electric power generation. Three out of the top ten Fortune 500 companies were oil/gas companies in 2011. This short introduction to the oil and gas industry will focus on history, operations, major companies, outside market forces, regulation and the current challenges the industry faces. Such factors as finite natural resources, the environment, economics, geopolitics, and technology will all come into play in the narrative. The book will demonstrate how the leaders of this industry, former champions of progress, are now coming under scrutiny and being depicted as the biggest culprits of environmental degradation. Yet the industry is likely to continue to grow until some form of alternate fuels is developed. The oil and gas industry will continue to have an enormous impact on life on the planet.