Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II'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

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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206

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National Academies Press

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ISBN 10

0309212804

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9780309212809

Front-of-Package Nutrition Rating Systems and Symbols

Promoting Healthier Choices

By: Institute of Medicine,Food and Nutrition Board,Committee on Examination of Front-of-Package Nutrition Rating Systems and Symbols (Phase II)

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Front-of-Package Nutrition Rating Systems and Symbols

Promoting Healthier Choices

By: Institute of Medicine,Food and Nutrition Board,Committee on Examination of Front-of-Package Nutrition Rating Systems and Symbols (Phase II)

During the past decade, tremendous growth has occurred in the use of nutrition symbols and rating systems designed to summarize key nutritional aspects and characteristics of food products. These symbols and the systems that underlie them have become known as front-of-package (FOP) nutrition rating systems and symbols, even though the symbols themselves can be found anywhere on the front of a food package or on a retail shelf tag. Though not regulated and inconsistent in format, content, and criteria, FOP systems and symbols have the potential to provide useful guidance to consumers as well as maximize effectiveness. As a result, Congress directed the Centers for Disease Control and Prevention (CDC) to undertake a study with the Institute of Medicine (IOM) to examine and provide recommendations regarding FOP nutrition rating systems and symbols. The study was completed in two phases. Phase I focused primarily on the nutrition criteria underlying FOP systems. Phase II builds on the results of Phase I while focusing on aspects related to consumer understanding and behavior related to the development of a standardized FOP system. Front-of-Package Nutrition Rating Systems and Symbols focuses on Phase II of the study. The report addresses the potential benefits of a single, standardized front-label food guidance system regulated by the Food and Drug Administration, assesses which icons are most effective with consumer audiences, and considers the systems/icons that best promote health and how to maximize their use.

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180

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National Academies Press

Published Date

ISBN 10

0309218233

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9780309218238

Poultry Inspection

The Basis for a Risk-Assessment Approach

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Food and Nutrition Board,Committee on Public Health Risk Assessment of Poultry Inspection Programs

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Poultry Inspection

The Basis for a Risk-Assessment Approach

By: National Research Council,Division on Earth and Life Studies,Commission on Life Sciences,Food and Nutrition Board,Committee on Public Health Risk Assessment of Poultry Inspection Programs

According to surveys, the public believes the chickens it is buying are wholesome. Poultry Inspection: The Basis for a Risk-Assessment Approach looks at current inspection procedures to determine how effective the Food Safety Inspection Service is in finding dangerous levels of contaminants and disease-producing microorganisms. The book first describes the history behind the current system, noting that the amount of poultry inspected has increased dramatically while techniques and regulations have remained constant since 1968. The steps involved in an inspection are then described, followed by a discussion of alternative and innovative inspection procedures. It then provides a risk-assessment model for poultry, including submodels for each stage of processing. Risk assessment is used to protect health, establish priorities, identify problems, and set acceptable levels of risk. The model is applied both to microbiological hazards and to chemical contaminants.

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177

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National Academies Press

Published Date

ISBN 10

0309037433

ISBN 13

9780309037433

Understanding Risk

Informing Decisions in a Democratic Society

By: National Research Council,Division of Behavioral and Social Sciences and Education,Board on Environmental Change and Society,Committee on Risk Characterization

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Understanding Risk

Informing Decisions in a Democratic Society

By: National Research Council,Division of Behavioral and Social Sciences and Education,Board on Environmental Change and Society,Committee on Risk Characterization

Understanding Risk addresses a central dilemma of risk decisionmaking in a democracy: detailed scientific and technical information is essential for making decisions, but the people who make and live with those decisions are not scientists. The key task of risk characterization is to provide needed and appropriate information to decisionmakers and the public. This important new volume illustrates that making risks understandable to the public involves much more than translating scientific knowledge. The volume also draws conclusions about what society should expect from risk characterization and offers clear guidelines and principles for informing the wide variety of risk decisions that face our increasingly technological society. Frames fundamental questions about what risk characterization means. Reviews traditional definitions and explores new conceptual and practical approaches. Explores how risk characterization should inform decisionmakers and the public. Looks at risk characterization in the context of the entire decisionmaking process. Understanding Risk discusses how risk characterization has fallen short in many recent controversial decisions. Throughout the text, examples and case studiesâ€"such as planning for the long-term ecological health of the Everglades or deciding on the operation of a waste incineratorâ€"bring key concepts to life. Understanding Risk will be important to anyone involved in risk issues: federal, state, and local policymakers and regulators; risk managers; scientists; industrialists; researchers; and concerned individuals.

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263

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National Academies Press

Published Date

ISBN 10

0309133246

ISBN 13

9780309133241

Setting Priorities for Health Technologies Assessment

A Model Process

By: Institute of Medicine,Committee on Priorities for Assessment and Reassessment of Health Care Technologies

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Setting Priorities for Health Technologies Assessment

A Model Process

By: Institute of Medicine,Committee on Priorities for Assessment and Reassessment of Health Care Technologies

The problem of deciding which health care technologies to evaluate is urgent. With new technologies proliferating alongside steadily increasing health care costs, it is critical to discriminate among technologies to direct tests and treatments at those who can benefit the most. Given the vast number of clinical problems and technologies to be evaluated, the many months of work required to study just one problem, and the relatively few clinicians with highly developed analytic skills, institutions must set priorities for assessment. This book sets forth criteria and a method that can be used by public agencies such as the Office of Health Technology Assessment (in the U.S. Public Health Service) and by any private organization conducting such work to decide which technologies to assess or reassess.

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163

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National Academies Press

Published Date

ISBN 10

0309046963

ISBN 13

9780309046961

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

ISBN 13

9780309164757

Public Health Effectiveness of the FDA 510(k) Clearance Process

Balancing Patient Safety and Innovation: Workshop Report

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process

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Public Health Effectiveness of the FDA 510(k) Clearance Process

Balancing Patient Safety and Innovation: Workshop Report

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process

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.

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141

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National Academies Press

Published Date

ISBN 10

0309162904

ISBN 13

9780309162906

Public Health Effectiveness of the FDA 510(k) Clearance Process

Measuring Postmarket Performance and Other Select Topics: Workshop Report

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process

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Public Health Effectiveness of the FDA 510(k) Clearance Process

Measuring Postmarket Performance and Other Select Topics: Workshop Report

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process

The Food and Drug Administration (FDA) is responsible for ensuring that medical devices are safe and effective before they go on the market. Section 510(k) of the Federal Food, Drug, and Cosmetic Act requires a manufacturer of medical devices to notify FDA of its intent to market a medical device at least 90 days in advance. That window of time allows FDA to evaluate whether the device is substantially equivalent to a product already legally on the market (called a predicate), in which case the device does not need to go through the premarket approval (PMA) process. As part of its assessment of the FDA's premarket clearance process for medical devices, the Institute of Medicine (IOM) held a workshop on July 28, 2010 to discuss how medical devices are monitored for safety after they are available to consumers. Its primary focus was on monitoring the safety of marketed medical devices, including FDA's postmarket surveillance activities, analysis of safety concerns that resulted in medical device recalls, and non-FDA sources of adverse-event information. Public Health Effectiveness of the FDA 501(K) Clearance Process summarizes the views of the workshop participants.

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132

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National Academies Press

Published Date

ISBN 10

0309162068

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9780309162067

Book's by Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II

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

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

Front-of-Package Nutrition Rating Systems and Symbols

Front-of-Package Nutrition Rating Systems and Symbols

Poultry Inspection

Poultry Inspection

Understanding Risk

Understanding Risk

Setting Priorities for Health Technologies Assessment

Setting Priorities for Health Technologies Assessment

Globalization, Biosecurity, and the Future of the Life Sciences

Globalization, Biosecurity, and the Future of the Life Sciences

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process

Public Health Effectiveness of the FDA 510(k) Clearance Process

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