Preparing for Future Products of Biotechnology PDF Download

Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309452058
Category : Science
Languages : en
Pages : 231

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Book Description
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.

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.

Author: Cary Coglianese
Publisher: University of Pennsylvania Press
ISBN: 0812207491
Category : Political Science
Languages : en
Pages : 290

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Book Description
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.

Author: Cary Coglianese
Publisher: University of Pennsylvania Press
ISBN: 081220591X
Category : Political Science
Languages : en
Pages : 304

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Book Description
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.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309162904
Category : Medical
Languages : en
Pages : 141

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Book Description
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.

Author: OECD
Publisher: OECD Publishing
ISBN: 9264116575
Category :
Languages : en
Pages : 155

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Book Description
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.

Author: Mahendra Rai
Publisher: John Wiley & Sons
ISBN: 1119769884
Category : Science
Languages : en
Pages : 448

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Book Description
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.

Author: Graham Russell
Publisher: Bloomsbury Publishing
ISBN: 1509918604
Category : Law
Languages : en
Pages : 505

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Book Description
This ground-breaking book addresses the challenge of regulatory delivery, defined as the way that regulatory agencies operate in practice to achieve the intended outcomes of regulation. Regulatory reform is moving beyond the design of regulation to address what good regulatory delivery looks like. The challenge in practice is to operate a regulatory regime that is both appropriate and effective. Questions of how regulations are received and applied by those whose behaviour they seek to control, and the way they are enforced, are vital in securing desired regulatory outcomes. This book, written by and for practitioners of regulatory delivery, explains the Regulatory Delivery Model, developed by Graham Russell and his team at the UK Department for Business, Energy and Industrial Strategy. The model sets out a framework to steer improvements to regulatory delivery, comprising three prerequisites for regulatory agencies to be able to operate effectively (Governance Frameworks, Accountability and Culture) and three practices for regulatory agencies to be able to deliver societal outcomes (Outcome Measurement, Risk-based Prioritisation and Intervention Choices). These elements are explored by an international group of experts in regulatory delivery reform, with case studies from around the world. Regulatory Delivery is the first product of members of the International Network for Delivery of Regulation.

Author: United States Government Accountability Office
Publisher: Lulu.com
ISBN: 0359541828
Category : Reference
Languages : en
Pages : 88

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Book Description
Policymakers and program managers are continually seeking ways to improve accountability in achieving an entity's mission. A key factor in improving accountability in achieving an entity's mission is to implement an effective internal control system. An effective internal control system helps an entity adapt to shifting environments, evolving demands, changing risks, and new priorities. As programs change and entities strive to improve operational processes and implement new technology, management continually evaluates its internal control system so that it is effective and updated when necessary. Section 3512 (c) and (d) of Title 31 of the United States Code (commonly known as the Federal Managers' Financial Integrity Act (FMFIA)) requires the Comptroller General to issue standards for internal control in the federal government.

Author: Peter Drahos
Publisher: ANU Press
ISBN: 1760461024
Category : Law
Languages : en
Pages : 820

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Book Description
This volume introduces readers to regulatory theory. Aimed at practitioners, postgraduate students and those interested in regulation as a cross-cutting theme in the social sciences, Regulatory Theory includes chapters on the social-psychological foundations of regulation as well as theories of regulation such as responsive regulation, smart regulation and nodal governance. It explores the key themes of compliance, legal pluralism, meta-regulation, the rule of law, risk, accountability, globalisation and regulatory capitalism. The environment, crime, health, human rights, investment, migration and tax are among the fields of regulation considered in this ground-breaking book. Each chapter introduces the reader to key concepts and ideas and contains suggestions for further reading. The contributors, who either are or have been connected to the Regulatory Institutions Network (RegNet) at The Australian National University, include John Braithwaite, Valerie Braithwaite, Peter Grabosky, Neil Gunningham, Fiona Haines, Terry Halliday, David Levi-Faur, Christine Parker, Colin Scott and Clifford Shearing.