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Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309212804 Category : Medical Languages : en Pages : 206
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309212804 Category : Medical Languages : en Pages : 206
Book Description
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.
Author: National Research Council Publisher: National Academies Press ISBN: 0309163587 Category : Medical Languages : en Pages : 589
Book Description
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.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309459575 Category : Medical Languages : en Pages : 483
Book Description
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.
Author: National Research Council Publisher: National Academies Press ISBN: 030930783X Category : Medical Languages : en Pages : 340
Book Description
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.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309218160 Category : Medical Languages : en Pages : 292
Book Description
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.
Author: Dennis J. Paustenbach Publisher: John Wiley & Sons ISBN: 1119551102 Category : Technology & Engineering Languages : en Pages : 1319
Book Description
Understand the fundamentals of human risk assessment with this introduction and reference Human risk assessments are a precondition for virtually all industrial action or environmental regulation, all the more essential in a world where chemical and environmental hazards are becoming more abundant. These documents catalog potential environmental, toxicological, ecological, or other harms resulting from a particular hazard, from chemical spills to construction projects to dangerous workplaces. They turn on a number of variables, of which the most significant is the degree of human exposure to the hazardous agent or process. Human and Ecological Risk Assessment combines the virtues of a textbook and reference work to introduce and analyze these vital documents. Beginning with the foundational theory of human health risk assessment, it then supplies case studies and detailed analysis illustrating the practice of producing risk assessment documents. Fully updated and authored by leading authorities in the field, the result is an indispensable work. Readers of the second edition of Human and Ecological Risk Assessment will also find: Over 40 entirely new case studies reflecting the latest in risk assessment practice Detailed discussion of hazards including air emissions, contaminated food and soil, hazardous waste sites, and many more Case studies from multiple countries to reflect diverse international standards Human and Ecological Risk Assessment is ideal for professionals and advanced graduate students in toxicology, industrial hygiene, occupational medicine, environmental science, and all related subjects.
Author: Chin-Yi Chen Publisher: Elsevier ISBN: 0128013370 Category : Technology & Engineering Languages : en Pages : 457
Book Description
Antimicrobial Resistance and Food Safety: Methods and Techniques introduces antimicrobial resistant food-borne pathogens, their surveillance and epidemiology, emerging resistance and resistant pathogens. This analysis is followed by a systematic presentation of currently applied methodology and technology, including advanced technologies for detection, intervention, and information technologies. This reference can be used as a practical guide for scientists, food engineers, and regulatory personnel as well as students in food safety, food microbiology, or food science. - Includes analysis of all major pathogens of concern - Provides many case studies and examples of fundamental research findings - Presents recent advances in methodologies and analytical software - Demonstrates risk assessment using information technologies in foodborne pathogens
Author: Institute of Medicine Publisher: National Academies Press ISBN: 0309290236 Category : Political Science Languages : en Pages : 280
Book Description
The U.S. Environmental Protection Agency (EPA) is one of several federal agencies responsible for protecting Americans against significant risks to human health and the environment. As part of that mission, EPA estimates the nature, magnitude, and likelihood of risks to human health and the environment; identifies the potential regulatory actions that will mitigate those risks and protect public health1 and the environment; and uses that information to decide on appropriate regulatory action. Uncertainties, both qualitative and quantitative, in the data and analyses on which these decisions are based enter into the process at each step. As a result, the informed identification and use of the uncertainties inherent in the process is an essential feature of environmental decision making. EPA requested that the Institute of Medicine (IOM) convene a committee to provide guidance to its decision makers and their partners in states and localities on approaches to managing risk in different contexts when uncertainty is present. It also sought guidance on how information on uncertainty should be presented to help risk managers make sound decisions and to increase transparency in its communications with the public about those decisions. Given that its charge is not limited to human health risk assessment and includes broad questions about managing risks and decision making, in this report the committee examines the analysis of uncertainty in those other areas in addition to human health risks. Environmental Decisions in the Face of Uncertainty explains the statement of task and summarizes the findings of the committee.
Author: Kofi Asante-Duah Publisher: Springer ISBN: 9402410392 Category : Medical Languages : en Pages : 603
Book Description
This book provides a concise, yet comprehensive overview of the many facets relating to human health risk assessments in relation to chemical exposure problems. It presents some very important tools and methodologies that can be used to address chemical exposure and public health risk management problems in a consistent, efficient, and cost-effective manner. On the whole, the book represents a collection and synthesis of the principal elements of the risk assessment process that may be used to more effectively address issues pertaining to human exposures to chemicals found in modern societies. This also includes an elaboration of pertinent risk assessment concepts and techniques/methodologies for performing human health risk assessments. Written for both the novice and the experienced, the subject matter of this book is an attempt at offering a simplified and systematic presentation of public health risk assessment methods and application tools – all these facilitated by a layout that will carefully navigate the user through the major processes involved. A number of illustrative example problems are interspersed throughout the book, in order to help present the book in an easy-to-follow, pragmatic manner.
Author: National Academies of Sciences, Engineering, and Medicine Publisher: National Academies Press ISBN: 0309453518 Category : Nature Languages : en Pages : 201
Book Description
Over the last decade, several large-scale United States and international programs have been initiated to incorporate advances in molecular and cellular biology, -omics technologies, analytical methods, bioinformatics, and computational tools and methods into the field of toxicology. Similar efforts are being pursued in the field of exposure science with the goals of obtaining more accurate and complete exposure data on individuals and populations for thousands of chemicals over the lifespan; predicting exposures from use data and chemical-property information; and translating exposures between test systems and humans. Using 21st Century Science to Improve Risk-Related Evaluations makes recommendations for integrating new scientific approaches into risk-based evaluations. This study considers the scientific advances that have occurred following the publication of the NRC reports Toxicity Testing in the 21st Century: A Vision and a Strategy and Exposure Science in the 21st Century: A Vision and a Strategy. Given the various ongoing lines of investigation and new data streams that have emerged, this publication proposes how best to integrate and use the emerging results in evaluating chemical risk. Using 21st Century Science to Improve Risk-Related Evaluations considers whether a new paradigm is needed for data validation, how to integrate the divergent data streams, how uncertainty might need to be characterized, and how best to communicate the new approaches so that they are understandable to various stakeholders.
Author: Institute of Medicine
Author: Institute of Medicine
Author: National Research Council
Author: National Academies of Sciences, Engineering, and Medicine
Author: National Research Council
Author: Institute of Medicine
Author: Dennis J. Paustenbach
Author: Chin-Yi Chen
Author: Institute of Medicine
Author: Kofi Asante-Duah
Author: National Academies of Sciences, Engineering, and Medicine