Product School'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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Page Count

206

Publisher

National Academies Press

Published Date

ISBN 10

0309212804

ISBN 13

9780309212809

Product Liability and Innovation

Managing Risk in an Uncertain Environment

By: National Academy of Engineering,Steering Committee on Product Liability and Innovation

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Product Liability and Innovation

Managing Risk in an Uncertain Environment

By: National Academy of Engineering,Steering Committee on Product Liability and Innovation

Product liability is a contentious issue. Proponents argue that American tort law promotes product safety. Manufacturers contend that lawsuits chill new product development. Product Liability and Innovation provides an overview and an engineering perspective on the product liability system. The volume offers studies of selected industries, exploring the effect of product liability on corporate product development decisions and on the creative opportunities and day-to-day work of engineers. The volume addresses the potential liability of the parts or materials supplier and discusses the impact of liability on the availability of insurance. It looks at "junk science" in the courtroom and analyzes opportunities to incorporate into product design what we know about human behavior and risk. The book also looks at current efforts at tort reform and compares U.S. injury claims handling with that of other countries. This volume will be important to policymakers, industrialists, attorneys, product engineers, and individuals concerned about the impact of product liability on the industrial future.

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Page Count

214

Publisher

National Academies Press

Published Date

ISBN 10

0309051304

ISBN 13

9780309051309

Assessing the Use of Agent-Based Models for Tobacco Regulation

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of Agent-Based Models to Inform Tobacco Product Regulation

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Assessing the Use of Agent-Based Models for Tobacco Regulation

By: Institute of Medicine,Board on Population Health and Public Health Practice,Committee on the Assessment of Agent-Based Models to Inform Tobacco Product Regulation

Tobacco consumption continues to be the leading cause of preventable disease and death in the United States. The Food and Drug Administration (FDA) regulates the manufacture, distribution, and marketing of tobacco products - specifically cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco - to protect public health and reduce tobacco use in the United States. Given the strong social component inherent to tobacco use onset, cessation, and relapse, and given the heterogeneity of those social interactions, agent-based models have the potential to be an essential tool in assessing the effects of policies to control tobacco. Assessing the Use of Agent-Based Models for Tobacco Regulation describes the complex tobacco environment; discusses the usefulness of agent-based models to inform tobacco policy and regulation; presents an evaluation framework for policy-relevant agent-based models; examines the role and type of data needed to develop agent-based models for tobacco regulation; provides an assessment of the agent-based model developed for FDA; and offers strategies for using agent-based models to inform decision making in the future.

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Page Count

269

Publisher

National Academies Press

Published Date

ISBN 10

0309317258

ISBN 13

9780309317252

The Scientific Basis of Tobacco Product Regulation

Second Report of a WHO Study Group

By: World Health Organization,WHO Study Group on Tobacco Product Regulation

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The Scientific Basis of Tobacco Product Regulation

Second Report of a WHO Study Group

By: World Health Organization,WHO Study Group on Tobacco Product Regulation

This report makes available the findings of an international group of experts that provide WHO with the latest scientific and technical advice in the area of product regulation. This second report presents policy recommendations on the topics of: smokeless tobacco products and their health effects, and implications for harm reduction and research needs; "fire safer" cigarettes and approaches to reduced ignition propensity; mandated lowering of toxicants in cigarette smoke, such as tobacco specific nitrosamines and other constituents; and, cigarette machine smoking regimens. The Study Group intends this new set of recommendations to be useful to WHO Member States, and national policymakers and regulators in shaping tobacco control policy.

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Page Count

290

Publisher

World Health Organization

Published Date

ISBN 10

9241209518

ISBN 13

9789241209519

Rare Diseases and Orphan Products

Accelerating Research and Development

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development

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Rare Diseases and Orphan Products

Accelerating Research and Development

By: Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

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Page Count

442

Publisher

National Academies Press

Published Date

ISBN 10

0309158060

ISBN 13

9780309158060

Advanced Reporting Guide for MicroStrategy 9.5

By: MicroStrategy Product Manuals,MicroStrategy

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Advanced Reporting Guide for MicroStrategy 9.5

By: MicroStrategy Product Manuals,MicroStrategy

The Advanced Reporting Guide includes instructions for advanced topics in the MicroStrategy system, building on information in the Basic Reporting Guide. Topics include reports, Freeform SQL reports, Query Builder reports, filters, metrics, Data Mining Services, custom groups, consolidations, and prompts.

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Page Count

1341

Publisher

MicroStrategy, Inc.

Published Date

ISBN 10

1938244753

ISBN 13

9781938244759

Book's by Product School

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

Product Liability and Innovation

Product Liability and Innovation

Assessing the Use of Agent-Based Models for Tobacco Regulation

Assessing the Use of Agent-Based Models for Tobacco Regulation

The Scientific Basis of Tobacco Product Regulation

The Scientific Basis of Tobacco Product Regulation

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products

Advanced Reporting Guide for MicroStrategy 9.5

Advanced Reporting Guide for MicroStrategy 9.5

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