Download or read book A Risk Characterization Framework for Decision Making at the Food and Drug Administration written by Institute of Medicine and published by National Academies Press. This book was released on 2011-06-26 with total page 206 pages. Available in PDF, EPUB and Kindle. Book excerpt: With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations.
Download or read book Risk characterization Framework for Decision making at the Food and Drug Administration written by and published by . This book was released on 2011 with total page 192 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Managing the Risks from Medical Product Use written by United States. Food and Drug Administration. Task Force on Risk Management and published by . This book was released on 1999 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-08-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Download or read book Managing the Risks from Medical Product Use written by and published by . This book was released on 1999 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Quality Risk Management in the FDA Regulated Industry written by José Rodríguez Pérez and published by Quality Press. This book was released on 2012-06-12 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that absolute safety (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.
Download or read book Risk assessment and risk management in regulatory decision making written by United States. Presidential/Congressional Commission on Risk Assessment and Risk Management and published by . This book was released on 1997 with total page 238 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book A Framework for Assessing Effects of the Food System written by National Research Council and published by National Academies Press. This book was released on 2015-06-17 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: How we produce and consume food has a bigger impact on Americans' well-being than any other human activity. The food industry is the largest sector of our economy; food touches everything from our health to the environment, climate change, economic inequality, and the federal budget. From the earliest developments of agriculture, a major goal has been to attain sufficient foods that provide the energy and the nutrients needed for a healthy, active life. Over time, food production, processing, marketing, and consumption have evolved and become highly complex. The challenges of improving the food system in the 21st century will require systemic approaches that take full account of social, economic, ecological, and evolutionary factors. Policy or business interventions involving a segment of the food system often have consequences beyond the original issue the intervention was meant to address. A Framework for Assessing Effects of the Food System develops an analytical framework for assessing effects associated with the ways in which food is grown, processed, distributed, marketed, retailed, and consumed in the United States. The framework will allow users to recognize effects across the full food system, consider all domains and dimensions of effects, account for systems dynamics and complexities, and choose appropriate methods for analysis. This report provides example applications of the framework based on complex questions that are currently under debate: consumption of a healthy and safe diet, food security, animal welfare, and preserving the environment and its resources. A Framework for Assessing Effects of the Food System describes the U.S. food system and provides a brief history of its evolution into the current system. This report identifies some of the real and potential implications of the current system in terms of its health, environmental, and socioeconomic effects along with a sense for the complexities of the system, potential metrics, and some of the data needs that are required to assess the effects. The overview of the food system and the framework described in this report will be an essential resource for decision makers, researchers, and others to examine the possible impacts of alternative policies or agricultural or food processing practices.
Download or read book Science and Decisions written by National Research Council and published by National Academies Press. This book was released on 2009-03-24 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: Risk assessment has become a dominant public policy tool for making choices, based on limited resources, to protect public health and the environment. It has been instrumental to the mission of the U.S. Environmental Protection Agency (EPA) as well as other federal agencies in evaluating public health concerns, informing regulatory and technological decisions, prioritizing research needs and funding, and in developing approaches for cost-benefit analysis. However, risk assessment is at a crossroads. Despite advances in the field, risk assessment faces a number of significant challenges including lengthy delays in making complex decisions; lack of data leading to significant uncertainty in risk assessments; and many chemicals in the marketplace that have not been evaluated and emerging agents requiring assessment. Science and Decisions makes practical scientific and technical recommendations to address these challenges. This book is a complement to the widely used 1983 National Academies book, Risk Assessment in the Federal Government (also known as the Red Book). The earlier book established a framework for the concepts and conduct of risk assessment that has been adopted by numerous expert committees, regulatory agencies, and public health institutions. The new book embeds these concepts within a broader framework for risk-based decision-making. Together, these are essential references for those working in the regulatory and public health fields.
Download or read book Ethical and Scientific Issues in Studying the Safety of Approved Drugs written by Institute of Medicine and published by National Academies Press. This book was released on 2012-07-30 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: An estimated 48 percent of the population takes at least one prescription drug in a given month. Drugs provide great benefits to society by saving or improving lives. Many drugs are also associated with side effects or adverse events, some serious and some discovered only after the drug is on the market. The discovery of new adverse events in the postmarketing setting is part of the normal natural history of approved drugs, and timely identification and warning about drug risks are central to the mission of the Food and Drug Administration (FDA). Not all risks associated with a drug are known at the time of approval, because safety data are collected from studies that involve a relatively small number of human subjects during a relatively short period. Written in response to a request by the FDA, Ethical and Scientific Issues in Studying the Safety of Approved Drugs discusses ethical and informed consent issues in conducting studies in the postmarketing setting. It evaluates the strengths and weaknesses of various approaches to generate evidence about safety questions, and makes recommendations for appropriate followup studies and randomized clinical trials. The book provides guidance to the FDA on how it should factor in different kinds of evidence in its regulatory decisions. Ethical and Scientific Issues in Studying the Safety of Approved Drugs will be of interest to the pharmaceutical industry, patient advocates, researchers, and consumer groups.
Download or read book Initiation and Conduct of All major Risk Assessments Within a Risk Analysis Framework written by and published by . This book was released on 2002 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Primer on Risk Analysis written by Charles Yoe and published by CRC Press. This book was released on 2019-01-18 with total page 294 pages. Available in PDF, EPUB and Kindle. Book excerpt: Primer on Risk Analysis: Decision Making Under Uncertainty, Second Edition lays out the tasks of risk analysis in a straightforward, conceptual manner, tackling the question, "What is risk analysis?" Distilling the common principles of many risk dialects into serviceable definitions, it provides a foundation for the practice of risk management and decision making under uncertainty for professionals from all disciplines. New in this edition is an expanded risk management emphasis that includes an overview chapter on enterprise risk management and a chapter on decision making under uncertainty designed to help decision makers use the results of risk analysis in practical ways to improve decisions and their outcomes. This book will empower you to enter the world of risk management in your own domain of expertise by providing you with practical, insightful, useful and adaptable knowledge of risk analysis science including risk management, risk assessment, and risk communication. Features: Answers the fundamental question, "What is Risk Analysis?" Presents the tasks of risk management, risk assessment, and risk communication in a straightforward, conceptual manner Responds to the continuing evolution of risk science and addresses the language of risk as it continues to evolve Expands the risk management emphasis with a new chapter to serve private industry and a growing public sector interest in the growing practice of enterprise risk management Includes a new chapter on decision making under uncertainty provides practical guidance and ideas for using risk science to improve decisions and their outcomes Features an expanded set of examples of the risk process that demonstrate the growing applications of risk analysis This book is suitable for executives, professionals and students who seek a fundamental understanding of risk management, risk assessment, and risk communication. A more detailed examination of this topic, suitable for practitioners from any discipline as well as students and professionals who aspire to become experts in the practice of risk analysis science, is found in Principles of Risk Analysis: Decision Making Under Uncertainty, Second Edition, ISBN: 978-1-138-47820-6.
Download or read book The Tolerability of Risk written by Frederic Bouder and published by Earthscan. This book was released on 2007 with total page 159 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is an increasing dissatisfaction about how risk is regulated, leading to vivid debates about the use of 'risk assessment' and 'precaution'. As a result, academics, government officials and industry leaders are calling for new approaches and fresh ideas. This book provides a historical and topical perspective on the alternative concept of 'Tolerability of Risk' and its concrete regulatory applications.In the UK, Tolerability of Risk has been developed into a sophisticated framework, particularly within the health and safety sectors. It is expected to guide decision-makers when applying their legal obligation of keeping risks as low as practically reasonable. Could Tolerability of Risk become a wider source of inspiration across the full scope of risk analysis and management?Written by leading academics and risk practitioners from industry and government, The Tolerability of Risk presents a summary of theoretical perspectives on risk approaches, providing a detailed elicitation of the methods and approaches used to build the Tolerability of Risk framework and examining the prospect of universal application of that framework. From nuclear power to environmental pollution, climate change and drug testing, the Tolerability of Risk framework may offer a workable, pragmatic solution for balancing risks against the costs involved in controlling them, as well as developing the institutional capacity to make effective decisions in all jurisdictions worldwide.
Download or read book Principles of Risk Analysis written by Charles Yoe and published by CRC Press. This book was released on 2019-01-30 with total page 873 pages. Available in PDF, EPUB and Kindle. Book excerpt: In every decision problem there are things we know and things we do not know. Risk analysis science uses the best available evidence to assess what we know while it is carefully intentional in the way it addresses the importance of the things we do not know in the evaluation of decision choices and decision outcomes. The field of risk analysis science continues to expand and grow and the second edition of Principles of Risk Analysis: Decision Making Under Uncertainty responds to this evolution with several significant changes. The language has been updated and expanded throughout the text and the book features several new areas of expansion including five new chapters. The book’s simple and straightforward style—based on the author’s decades of experience as a risk analyst, trainer, and educator—strips away the mysterious aura that often accompanies risk analysis. Features: Details the tasks of risk management, risk assessment, and risk communication in a straightforward, conceptual manner Provides sufficient detail to empower professionals in any discipline to become risk practitioners Expands the risk management emphasis with a new chapter to serve private industry and a growing public sector interest in the growing practice of enterprise risk management Describes dozens of quantitative and qualitative risk assessment tools in a new chapter Practical guidance and ideas for using risk science to improve decisions and their outcomes is found in a new chapter on decision making under uncertainty Practical methods for helping risk professionals to tell their risk story are the focus of a new chapter Features an expanded set of examples of the risk process that demonstrate the growing applications of risk analysis As before, this book continues to appeal to professionals who want to learn and apply risk science in their own professions as well as students preparing for professional careers. This book remains a discipline free guide to the principles of risk analysis that is accessible to all interested practitioners. Files used in the creation of this book and additional exercises as well as a free student version of Palisade Corporation’s Decision Tools Suite software are available with the purchase of this book. A less detailed introduction to the risk analysis science tasks of risk management, risk assessment, and risk communication is found in Primer of Risk Analysis: Decision Making Under Uncertainty, Second Edition, ISBN: 978-1-138-31228-9.
Download or read book The Future of Drug Safety written by Institute of Medicine and published by National Academies Press. This book was released on 2007-02-27 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
