Download or read book Genetically Modified Pest Protected Plants written by National Research Council and published by National Academies Press. This book was released on 2000-08-23 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores the risks and benefits of crops that are genetically modified for pest resistance, the urgency of establishing an appropriate regulatory framework for these products, and the importance of public understanding of the issues. The committee critically reviews federal policies toward transgenic products, the 1986 coordinated framework among the key federal agencies in the field, and rules proposed by the Environmental Protection Agency for regulation of plant pesticides. This book provides detailed analyses of: Mechanisms and results of genetic engineering compared to conventional breeding for pest resistance. Review of scientific issues associated with transgenic pest-protected plants, such as allergenicity, impact on nontarget plants, evolution of the pest species, and other concerns. Overview of regulatory framework and its use of scientific information with suggestions for improvements.

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Download or read book Regulatory Breakdown written by Cary Coglianese and published by University of Pennsylvania Press. This book was released on 2012-08-16 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation brings fresh insight and analytic rigor to what has become one of the most contested domains of American domestic politics. Critics from the left blame lax regulation for the housing meltdown and financial crisis—not to mention major public health disasters ranging from the Gulf Coast oil spill to the Upper Big Branch Mine explosion. At the same time, critics on the right disparage an excessively strict and costly regulatory system for hampering economic recovery. With such polarized accounts of regulation and its performance, the nation needs now more than ever the kind of dispassionate, rigorous scholarship found in this book. With chapters written by some of the nation's foremost economists, political scientists, and legal scholars, Regulatory Breakdown brings clarity to the heated debate over regulation by dissecting the disparate causes of the current crisis as well as analyzing promising solutions to what ails the U.S. regulatory system. This volume shows policymakers, researchers, and the public why they need to question conventional wisdom about regulation—whether from the left or the right—and demonstrates the value of undertaking systematic analysis before adopting policy reforms in the wake of disaster.

Download or read book Ensuring Safe Food written by Committee to Ensure Safe Food from Production to Consumption and published by National Academies Press. This book was released on 1998-09-02 with total page 209 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Financial Regulation Recent Crisis Reaffirms the Need to Overhaul the U S Regulatory System written by Richard J. Hillman and published by DIANE Publishing. This book was released on 2011 with total page 25 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is a print on demand edition of a hard to find publication. In the midst of the worst economic crisis affecting financial markets globally in more than 75 years, fed. officials have taken unprecedented steps to stem the unraveling of the financial services sector. While these actions aimed to provide relief in the short term, the severity of the crisis has shown clearly that in the long term, the current U.S. financial regulatory system was in need of significant reform. This testimony discusses: (1) how regulation has evolved and the significant limitations and gaps in the existing regulatory system; (2) the experiences of countries with other types of varying regulatory structures during the financial crisis; and (3) how certain aspects of proposals would reform the U.S. regulatory system. Charts and tables.

Download or read book Financial Regulation A Framework for Crafting and Assessing Proposals to Modernize the Outdated U S Financial Regulatory System written by Gene L. Dodaro and published by DIANE Publishing. This book was released on 2010-02 with total page 30 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discusses a report that provides a framework for modernizing the outdated U.S. financial regulatory system. This report was prepared to help policymakers weigh various regulatory reform proposals and consider ways in which the current regulatory system could be made more effective and efficient. This testimony: (1) describes how regulation has evolved in banking, securities, thrifts, credit unions, futures, insurance, secondary mortgage markets and other areas; (2) describes several key changes in financial markets and products in recent decades that have highlighted significant limitations and gaps in the existing regulatory system; and (3) presents an evaluation framework that can be used by Congress to shape regulatory reform efforts.

Download or read book Public Health Effectiveness of the FDA 510 k Clearance Process written by Institute of Medicine and published by National Academies Press. This book was released on 2010-10-04 with total page 141 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Download or read book Import Safety written by Cary Coglianese and published by University of Pennsylvania Press. This book was released on 2011-09-28 with total page 304 pages. Available in PDF, EPUB and Kindle. Book excerpt: On World Food Day in October 2008, former president Bill Clinton finally accepted decade-old criticism directed at his administration's pursuit of free-trade deals with little regard for food safety, child labor, or workers' rights. "We all blew it, including me when I was president. We blew it. We were wrong to believe that food was like some other product in international trade." Clinton's public admission came at a time when consumers in the United States were hearing unsettling stories about contaminated food, toys, and medical products from China, and the first real calls were being made for more regulation of imported products. Import Safety comes at a moment when public interest is engaged with the subject and the government is receptive to the idea of consumer protections that were not instituted when many of the Clinton era's free-trade pacts were drafted. Written by leading scholars and analysts, the chapters in Import Safety provide background and policy guidance on improving consumer safety in imported food, pharmaceuticals, medical devices, and toys and other products aimed at children. Together, they consider whether policymakers should approach import safety issues through better funding of traditional interventions—such as regulatory oversight and product liability—or whether this problem poses a different kind of governance challenge, requiring wholly new methods.

Download or read book Modernizing Financial Regulation written by Lawrence P. Cowell and published by Nova Science Pub Incorporated. This book was released on 2010 with total page 183 pages. Available in PDF, EPUB and Kindle. Book excerpt: The current U.S. financial regulatory system has relied on a fragmented and complex arrangement of federal and state regulators, put into place over the past 150 years, that has not kept pace with major developments in financial markets and products in recent decades. As the nation finds itself in the midst of one of the worst financial crises ever, the regulatory system increasingly appears to be ill-suited to meet the nation's needs in the 21st century. This book explores a framework for modernising the outdated U.S. financial regulatory system to help policymakers weigh various regulatory reform proposals and consider ways in which the current regulatory system could be made more effective and efficient.

Download or read book The Federal Financial Institutions Regulatory System written by United States. Congress. House. Committee on Banking and Financial Services and published by . This book was released on 1996 with total page 234 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Regulating Medicines in a Globalized World written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-25 with total page 169 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book Regulatory Policy and Governance Supporting Economic Growth and Serving the Public Interest written by OECD and published by OECD Publishing. This book was released on 2011-10-25 with total page 155 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report encourages governments to “think big” about the relevance of regulatory policy and assesses the recent efforts of OECD countries to develop and deepen regulatory policy and governance.

Download or read book Handbook for Evaluating Infrastructure Regulatory Systems written by Ashley C. Brown and published by World Bank Publications. This book was released on 2006-01-01 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: More than 200 new infrastructure regulators have been created around the world in the last 15 years. They were established to encourage clear and sustainable long-term economic and legal commitments by governments and investors to encourage new investment to benefit existing and new customers. There is now considerable evidence that both investors and consumers-the two groups that were supposed to have benefited from these new regulatory systems-have often been disappointed with their performance. The fundamental premise of this book is that regulatory systems can be successfully reformed only if there are independent, objective and public evaluations of their performance. Just as one goes to a medical doctor for a regular health checkup, it is clear that infrastructure regulation would also benefit from periodic checkups. This book provides a general framework as well as detailed practical guidance on how to perform such "regulatory checkups."

Download or read book Regulatory System Strengthening in the Americas written by Pan American Health Organization and published by Pan American Health Organization. This book was released on 2021-04-23 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving access to safe, effective, and quality medicines and other health technologies is a critical public health priority and a fundamental requisite for universal health. National regulatory systems play a key part in a country's health system by overseeing the safety, quality, and efficacy of all health technologies, including pharmaceuticals, vaccines, blood and blood products, and medical devices, among others. The aim of this document is to better understand the regulatory landscape of the Americas, with an emphasis on Latin American National Regulatory Authorities of Reference. This report presents data and analysis corresponding to essential regulatory functions and systems foundations to understand current practices, identify critical issues, and present a series of recommendations for action. The report also includes an overview of the market outlook and economic integration mechanisms in the Americas and their influence on regulatory policy and pharmaceutical trade. In addition, the report includes a supplement to describe salient regulatory emergency responses to the COVID-19 pandemic in the Americas. Through this report, the Pan American Health Organization aims to increase the understanding of national regulatory remits and capacity in the Americas, raise awareness and appreciation of the regional regulatory progress and challenges, identify the regulatory issues emerging markets will bring, and highlight opportunities for evidence-based regulatory system strengthening.

Download or read book Reclaiming Development in the World Trading System written by Yong-Shik Lee and published by Cambridge University Press. This book was released on 2016-10-20 with total page 519 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this second edition, Lee provides extensive coverage of international trade law from an economic development perspective.

Download or read book Nanotechnology in Medicine written by Mahendra Rai and published by John Wiley & Sons. This book was released on 2021-10-19 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: NANOTECHNOLOGY IN MEDICINE Discover thorough insights into the toxicology of nanomaterials used in medicine In Nanotechnology in Medicine: Toxicity and Safety, an expert team of nanotechnologists delivers a robust and up-to-date review of current and future applications of nanotechnology in medicine with a special focus on neurodegenerative diseases, cancer, diagnostics, nano-nutraceuticals, dermatology, and gene therapy. The editors offer resources that address nanomaterial safety, which tends to be the greatest hurdle to obtaining the benefits of nanomedicine in healthcare. The book is a one-stop resource for recent and comprehensive information on the toxico logical and safety aspects of nanotechnology used in human health and medicine. It provides readers with cutting-edge techniques for delivering therapeutic agents into targeted cellular compartments, cells, tissues, and organs by using nanoparticulate carriers. The book also offers methodological considerations for toxicity, safety, and risk assessment. Nanotechnology in Medicine: Toxicity and Safety also provides readers with: A thorough introduction to the nanotoxicological aspects of nanomedicine, including translational nanomedicine and nanomedicine personalization Comprehensive introductions to nanoparticle toxicity and safety, including selenium nanoparticles and metallic nanoparticles Practical discussions of nanotoxicology and drug delivery, including gene delivery using nanocarriers and the use of nanomaterials for ocular delivery applications In-depth examinations of nanotechnology ethics and the regulatory framework of nanotechnology and medicine Perfect for researchers, post-doctoral candidates, and specialists in the fields of nanotechnology, nanomaterials, and nanocarriers, Nanotechnology in Medicine: Toxicity and Safety will also prove to be an indispensable part of the libraries of nanoengineering, nanomedicine, and biopharmaceutical professionals and nanobiotechnologists.

Download or read book Radiation in Medicine written by Institute of Medicine and published by National Academies Press. This book was released on 1996-04-25 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: Does radiation medicine need more regulation or simply better-coordinated regulation? This book addresses this and other questions of critical importance to public health and safety. The issues involved are high on the nation's agenda: the impact of radiation on public safety, the balance between federal and state authority, and the cost-benefit ratio of regulation. Although incidents of misadministration are rare, a case in Pennsylvania resulting in the death of a patient and the inadvertent exposure of others to a high dose of radiation drew attention to issues concerning the regulation of ionizing radiation in medicine and the need to examine current regulatory practices. Written at the request from the Nuclear Regulatory Commission (NRC), Radiation in Medicine reviews the regulation of ionizing radiation in medicine, focusing on the NRC's Medical Use Program, which governs the use of reactor-generated byproduct materials. The committee recommends immediate action on enforcement and provides longer term proposals for reform of the regulatory system. The volume covers: Sources of radiation and their use in medicine. Levels of risk to patients, workers, and the public. Current roles of the Nuclear Regulatory Commission, other federal agencies, and states. Criticisms from the regulated community. The committee explores alternative regulatory structures for radiation medicine and explains the rationale for the option it recommends in this volume. Based on extensive research, input from the regulated community, and the collaborative efforts of experts from a range of disciplines, Radiation in Medicine will be an important resource for federal and state policymakers and regulators, health professionals involved in radiation treatment, developers and producers of radiation equipment, insurance providers, and concerned laypersons.