Profiles of Regulatory Agencies of the United States and Canada PDF Download

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Publisher:
ISBN:
Category :
Languages : en
Pages : 546

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Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309498635
Category : Medical
Languages : en
Pages : 169

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Book Description
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
ISBN: 0309103045
Category : Medical
Languages : en
Pages : 347

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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
ISBN: 1000149145
Category : Language Arts & Disciplines
Languages : en
Pages : 255

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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: World Bank
Publisher: World Bank Publications
ISBN: 1464814414
Category : Business & Economics
Languages : en
Pages : 254

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Seventeen in a series of annual reports comparing business regulation in 190 economies, Doing Business 2020 measures aspects of regulation affecting 10 areas of everyday business activity.

Author:
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ISBN:
Category : Periodicals
Languages : en
Pages : 1536

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A union list of serials commencing publication after Dec. 31, 1949.

Author: OECD
Publisher: OECD Publishing
ISBN: 926408293X
Category :
Languages : en
Pages : 251

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This publication presents recent OECD papers on risk and regulatory policy. They offer measures for developing, or improving, coherent risk governance policies.

Author: William Leiss
Publisher: McGill-Queen's Press - MQUP
ISBN: 0773564675
Category : Medical
Languages : en
Pages : 422

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Book Description
William Leiss and Christina Chociolko explain that controversies arise in part because many participants try to avoid assuming full responsibility for the consequences of the risk-taking they advocate. For example, one can indulge in the pleasure of nicotine addiction despite an awareness of the health risks and count on a publicly funded health care system to assume the responsibility for dealing with the resulting illnesses. They provide detailed case studies of the controversies over the effects of exposure to power frequency electric and magnetic fields and to the chemical pesticides alar and antisapstains. Shorter studies of exposure to tobacco, formaldehyde, and the pesticide alachlor are also presented. The authors address the difficulties of arriving at reliable scientific estimates of risk in such controversial areas, and the impact of this uncertainty on disagreements among different interest groups over how to manage those risks responsibly. In conclusion they attempt to delineate conditions under which consensus on the assessment and management of environmental health risks might be achieved among a wide range of interest groups. Risk and Responsibility will be of specific interest to policymakers and analysts, activists, and environmentalists, and of general interest to those working in relevant industries and members of the legal profession.

Author: Linda Herkenhoff
Publisher: Business Expert Press
ISBN: 1606495011
Category : Business & Economics
Languages : en
Pages : 101

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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.

Author: Institute of Medicine and National Research Council
Publisher: National Academies Press
ISBN: 0309173973
Category : Medical
Languages : en
Pages : 208

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Book Description
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.