Product Regulation And Chemical Innovation
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Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 118 |
Release | : 2012-04-04 |
Genre | : Medical |
ISBN | : 0309222176 |
The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Author | : Christopher T. Hill |
Publisher | : |
Total Pages | : 232 |
Release | : 1979 |
Genre | : Law |
ISBN | : |
Author | : Institute of Medicine |
Publisher | : National Academies Press |
Total Pages | : 225 |
Release | : 1991-02-01 |
Genre | : Medical |
ISBN | : 030904491X |
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author | : National Research Council |
Publisher | : National Academies Press |
Total Pages | : 288 |
Release | : 1987-02-01 |
Genre | : Medical |
ISBN | : 0309037468 |
Concern about health effects from exposure to pesticides in foods is growing as scientists learn more about the toxic properties of pesticides. The Delaney Clause, a provision of the Food, Drug and Cosmetic Act, prohibits tolerances for any pesticide that causes cancer in test animals or in humans if the pesticide concentrates in processed food or feeds. This volume examines the impacts of the Delaney Clause on agricultural innovation and on the public's dietary exposure to potentially carcinogenic pesticide residues. Four regulatory scenarios are described to illustrate the effects of varying approaches to managing oncogenic pesticide residues in food.
Author | : National Academies of Sciences, Engineering, and Medicine |
Publisher | : National Academies Press |
Total Pages | : 231 |
Release | : 2017-07-28 |
Genre | : Science |
ISBN | : 0309452058 |
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 | : United States. Congress. House. Committee on Government Operations. Environment, Energy, and Natural Resources Subcommittee |
Publisher | : |
Total Pages | : 700 |
Release | : 1989 |
Genre | : Chemicals |
ISBN | : |
Author | : Richard Owen |
Publisher | : John Wiley & Sons |
Total Pages | : 361 |
Release | : 2013-03-21 |
Genre | : Business & Economics |
ISBN | : 1118551400 |
Science and innovation have the power to transform our lives and the world we live in - for better or worse – in ways that often transcend borders and generations: from the innovation of complex financial products that played such an important role in the recent financial crisis to current proposals to intentionally engineer our Earth’s climate. The promise of science and innovation brings with it ethical dilemmas and impacts which are often uncertain and unpredictable: it is often only once these have emerged that we feel able to control them. How do we undertake science and innovation responsibly under such conditions, towards not only socially acceptable, but socially desirable goals and in a way that is democratic, equitable and sustainable? Responsible innovation challenges us all to think about our responsibilities for the future, as scientists, innovators and citizens, and to act upon these. This book begins with a description of the current landscape of innovation and in subsequent chapters offers perspectives on the emerging concept of responsible innovation and its historical foundations, including key elements of a responsible innovation approach and examples of practical implementation. Written in a constructive and accessible way, Responsible Innovation includes chapters on: Innovation and its management in the 21st century A vision and framework for responsible innovation Concepts of future-oriented responsibility as an underpinning philosophy Values – sensitive design Key themes of anticipation, reflection, deliberation and responsiveness Multi – level governance and regulation Perspectives on responsible innovation in finance, ICT, geoengineering and nanotechnology Essentially multidisciplinary in nature, this landmark text combines research from the fields of science and technology studies, philosophy, innovation governance, business studies and beyond to address the question, “How do we ensure the responsible emergence of science and innovation in society?”
Author | : Simone Maranghi |
Publisher | : Springer Nature |
Total Pages | : 172 |
Release | : 2020-02-05 |
Genre | : Science |
ISBN | : 303034424X |
This book outlines the methodologies, approaches and tools for modelling chemicals in a Life Cycle Assessment (LCA) perspective, and also covers the main advantages and drawbacks of applying LCA to chemical processes. In the first part of this book, authors pay close attention to the limitations of modelling the environmental and social impacts of chemical processes, providing valuable insights to the problems of the Life Cycle Inventory (LCI) analysis for chemical processes. In the second part of this book, readers will learn about the LCA application to chemical processes in the laboratory and industrial scale. In each chapter of this book, readers will also find specific case studies on the modelling and application of LCA in the chemical industry.
Author | : National Research Council |
Publisher | : National Academies Press |
Total Pages | : 158 |
Release | : 2015-06-29 |
Genre | : Science |
ISBN | : 0309316553 |
The tremendous progress in biology over the last half century - from Watson and Crick's elucidation of the structure of DNA to today's astonishing, rapid progress in the field of synthetic biology - has positioned us for significant innovation in chemical production. New bio-based chemicals, improved public health through improved drugs and diagnostics, and biofuels that reduce our dependency on oil are all results of research and innovation in the biological sciences. In the past decade, we have witnessed major advances made possible by biotechnology in areas such as rapid, low-cost DNA sequencing, metabolic engineering, and high-throughput screening. The manufacturing of chemicals using biological synthesis and engineering could expand even faster. A proactive strategy - implemented through the development of a technical roadmap similar to those that enabled sustained growth in the semiconductor industry and our explorations of space - is needed if we are to realize the widespread benefits of accelerating the industrialization of biology. Industrialization of Biology presents such a roadmap to achieve key technical milestones for chemical manufacturing through biological routes. This report examines the technical, economic, and societal factors that limit the adoption of bioprocessing in the chemical industry today and which, if surmounted, would markedly accelerate the advanced manufacturing of chemicals via industrial biotechnology. Working at the interface of synthetic chemistry, metabolic engineering, molecular biology, and synthetic biology, Industrialization of Biology identifies key technical goals for next-generation chemical manufacturing, then identifies the gaps in knowledge, tools, techniques, and systems required to meet those goals, and targets and timelines for achieving them. This report also considers the skills necessary to accomplish the roadmap goals, and what training opportunities are required to produce the cadre of skilled scientists and engineers needed.
Author | : Jonathan B. Tucker |
Publisher | : MIT Press |
Total Pages | : 367 |
Release | : 2012 |
Genre | : History |
ISBN | : 0262017172 |
Recent advances in disciplines such as biotechnology, nanotechnology, and neuropharmacology entail a "dual-use dilemma" because they promise benefits for human health and welfare yet pose the risk of misuse for hostile purposes. The emerging field of synthetic genomics, for example, can produce custom DNA molecules for life-saving drugs but also makes possible the creation of deadly viral agents for biological warfare or terrorism. The challenge for policymakers is to prevent the misuse of these new technologies without forgoing their benefits . Innovation, Dual Use, and Security offers a systematic approach for managing the dual-use dilemma. The book presents a "decision framework" for assessing the security risks of emerging technologies and fashioning governance strategies to manage those risks. This framework is applied to fourteen contemporary case studies, including synthetic genomics, DNA shuffling and directed evolution, combinatorial chemistry, protein engineering, immunological modulation, and aerosol vaccines. The book also draws useful lessons from two historical cases: the development of the V-series nerve agents in Britain and the use and misuse of LSD by the U.S. Army and the CIA. Innovation, Dual Use, and Security offers a comprehensive, multifaceted introduction to the challenges of governing dual-use technologies in an era of rapid innovation. The book will be of interest to government officials and other practitioners as well as to students and scholars in security studies, science and technology studies, biology, and chemistry.