National Academies (U.S.). Committee on Ranking FDA Product Categories Based on Health Consequences's Books

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

By: Institute of Medicine,National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II

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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

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.

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206

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National Academies Press

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ISBN 10

0309212804

ISBN 13

9780309212809

School Meals

Building Blocks for Healthy Children

By: Committee on Nutrition Standards for National School Lunch and Breakfast Programs,Institute of Medicine

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School Meals

Building Blocks for Healthy Children

By: Committee on Nutrition Standards for National School Lunch and Breakfast Programs,Institute of Medicine

Ensuring that the food provided to children in schools is consistent with current dietary recommendations is an important national focus. Various laws and regulations govern the operation of school meal programs. In 1995, Nutrition Standards and Meal Requirements were put in place to ensure that all meals offered would be high in nutritional quality. School Meals reviews and provides recommendations to update the nutrition standard and the meal requirements for the National School Breakfast and Lunch Programs. The recommendations reflect new developments in nutrition science, increase the availability of key food groups in the school meal programs, and allow these programs to better meet the nutritional needs of children, foster healthy eating habits, and safeguard children's health. School Meals sets standards for menu planning that focus on food groups, calories, saturated fat, and sodium and that incorporate Dietary Guidelines for Americans and the Dietary Reference Intakes. This book will be used as a guide for school food authorities, food producers, policy leaders, state/local governments, and parents.

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395

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National Academies Press

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ISBN 10

0309151376

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9780309151375

Enhancing Food Safety

The Role of the Food and Drug Administration

By: National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Committee on the Review of the Food and Drug Administration's Role in Ensuring Safe Food

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Enhancing Food Safety

The Role of the Food and Drug Administration

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.

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589

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National Academies Press

Published Date

ISBN 10

0309163587

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9780309163583

Identifying Future Drinking Water Contaminants

By: National Research Council,Division on Earth and Life Studies,Commission on Geosciences, Environment and Resources,1998 Workshop on Emerging Drinking Water Contaminants

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Identifying Future Drinking Water Contaminants

By: National Research Council,Division on Earth and Life Studies,Commission on Geosciences, Environment and Resources,1998 Workshop on Emerging Drinking Water Contaminants

With an increasing population, use of new and diverse chemicals that can enter the water supply, and emergence of new microbial pathogens, the U.S. federal government is faced with a regulatory dilemma: Where should it focus its attention and limited resources to ensure safe drinking water supplies for the future? Identifying Future Drinking Water Contaminants is based on a 1998 workshop on emerging drinking water contaminants. It includes a dozen papers that were presented on new and emerging microbiological and chemical drinking water contaminants, associated analytical and water treatment methods for their detection and removal, and existing and proposed environmental databases to assist in their proactive identification and regulation. The papers are preceded by a conceptual approach and related recommendations to EPA for the periodic creation of future Drinking Water Contaminant Candidate Lists (CCLsâ€"produced every five yearsâ€"include currently unregulated chemical and microbiological substances that are known or anticipated to occur in public water systems and that may pose health risks).

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277

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National Academies Press

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ISBN 10

0309064325

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9780309064323

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

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A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

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National Academies Press

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0309212804

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9780309212809

Stronger Food and Drug Regulatory Systems Abroad

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad

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Stronger Food and Drug Regulatory Systems Abroad

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad

Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone. The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress. The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.

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243

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National Academies Press

Published Date

ISBN 10

0309670438

ISBN 13

9780309670432

Health Risks from Dioxin and Related Compounds

Evaluation of the EPA Reassessment

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on EPA's Exposure and Human Health Reassessment of TCDD and Related Compounds

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Health Risks from Dioxin and Related Compounds

Evaluation of the EPA Reassessment

By: National Research Council,Division on Earth and Life Studies,Board on Environmental Studies and Toxicology,Committee on EPA's Exposure and Human Health Reassessment of TCDD and Related Compounds

Although the U.S. Environmental Protection Agency presented a comprehensive review of the scientific literature in its 2003 draft reassessment of the risks of dioxin, the agency did not sufficiently quantify the uncertainties and variabilities associated with the risks, nor did it adequately justify the assumptions used to estimate them, according to this new report from the National Academies' National Research Council. The committee that wrote the report recommended that EPA re-estimate the risks using several different assumptions and better communicate the uncertainties in those estimates. The agency also should explain more clearly how it selects both the data upon which the reassessment is based and the methods used to analyze them.

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269

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National Academies Press

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ISBN 10

0309102588

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9780309102582

Globalization, Biosecurity, and the Future of the Life Sciences

By: National Research Council,Institute of Medicine,Board on Global Health,Policy and Global Affairs,Development, Security, and Cooperation,Committee on Advances in Technology and the Prevention of Their Application to Next Generation Biowarfare Threats

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Globalization, Biosecurity, and the Future of the Life Sciences

Biomedical advances have made it possible to identify and manipulate features of living organisms in useful ways-leading to improvements in public health, agriculture, and other areas. The globalization of scientific and technical expertise also means that many scientists and other individuals around the world are generating breakthroughs in the life sciences and related technologies. The risks posed by bioterrorism and the proliferation of biological weapons capabilities have increased concern about how the rapid advances in genetic engineering and biotechnology could enable the production of biological weapons with unique and unpredictable characteristics. Globalization, Biosecurity, and the Future of Life Sciences examines current trends and future objectives of research in public health, life sciences, and biomedical science that contain applications relevant to developments in biological weapons 5 to 10 years into the future and ways to anticipate, identify, and mitigate these dangers.

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316

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National Academies Press

Published Date

ISBN 10

0309164753

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9780309164757

Stronger Food and Drug Regulatory Systems Abroad

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad

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Stronger Food and Drug Regulatory Systems Abroad

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Stronger Food and Drug Regulatory Systems Abroad

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243

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National Academies Press

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ISBN 10

0309670462

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9780309670463

Regulating Medicines in a Globalized World

The Need for Increased Reliance Among Regulators

By: National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Global Health,Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines

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Regulating Medicines in a Globalized World

The Need for Increased Reliance Among Regulators

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.

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169

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National Academies Press

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ISBN 10

030949866X

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9780309498661

Dietary Supplements

A Framework for Evaluating Safety

By: Committee on the Framework for Evaluating the Safety of the Dietary Supplements,Institute of Medicine,National Research Council

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Dietary Supplements

A Framework for Evaluating Safety

By: Committee on the Framework for Evaluating the Safety of the Dietary Supplements,Institute of Medicine,National Research Council

The growing consumer interest in health and fitness has expanded the market for a wide range of products, from yoga mats to the multiple dietary supplements now on the market. Supplements are popular, but are they safe? Many dietary supplements are probably safe when used as recommended. However, since 1994 when Congress decided that they should be regulated as if they were foods, they are assumed to be safe unless the Food and Drug Administration can demonstrate that they pose a significant risk to the consumer. But there are many types of products that qualify as dietary supplements, and the distinctions can become muddled and vague. Manufacturers are not legally required to provide specific information about safety before marketing their products. And the sales of supplements have been steadily increasingall together, the various types now bring in almost $16 billion per year. Given these confounding factors, what kind of information can the Food and Drug Administration use to effectively regulate dietary supplements? This book provides a framework for evaluating dietary supplement safety and protecting the health of consumers.

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526

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National Academies Press

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0309531888

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9780309531887

Book's by National Academies (U.S.). Committee on Ranking FDA Product Categories Based on Health Consequences

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

School Meals

School Meals

Enhancing Food Safety

Enhancing Food Safety

Identifying Future Drinking Water Contaminants

Identifying Future Drinking Water Contaminants

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

Stronger Food and Drug Regulatory Systems Abroad

Stronger Food and Drug Regulatory Systems Abroad

Health Risks from Dioxin and Related Compounds

Health Risks from Dioxin and Related Compounds

Globalization, Biosecurity, and the Future of the Life Sciences

Globalization, Biosecurity, and the Future of the Life Sciences

Stronger Food and Drug Regulatory Systems Abroad

Stronger Food and Drug Regulatory Systems Abroad

Regulating Medicines in a Globalized World

Regulating Medicines in a Globalized World

Dietary Supplements

Dietary Supplements

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