The Role Of Analysis In Regulatory Decisionmaking

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Models in Environmental Regulatory Decision Making

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309110009
Total Pages : 286 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Models in Environmental Regulatory Decision Making by : National Research Council

Download or read book Models in Environmental Regulatory Decision Making written by National Research Council and published by National Academies Press. This book was released on 2007-08-25 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many regulations issued by the U.S. Environmental Protection Agency (EPA) are based on the results of computer models. Models help EPA explain environmental phenomena in settings where direct observations are limited or unavailable, and anticipate the effects of agency policies on the environment, human health and the economy. Given the critical role played by models, the EPA asked the National Research Council to assess scientific issues related to the agency's selection and use of models in its decisions. The book recommends a series of guidelines and principles for improving agency models and decision-making processes. The centerpiece of the book's recommended vision is a life-cycle approach to model evaluation which includes peer review, corroboration of results, and other activities. This will enhance the agency's ability to respond to requirements from a 2001 law on information quality and improve policy development and implementation.

The Role of Analysis in Regulatory Decisionmaking: The Case of Cable Television

Author :
Publisher :
ISBN 13 :
Total Pages : 174 pages
Book Rating : 4.:/5 (227 download)

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Book Synopsis The Role of Analysis in Regulatory Decisionmaking: The Case of Cable Television by :

Download or read book The Role of Analysis in Regulatory Decisionmaking: The Case of Cable Television written by and published by . This book was released on 1972 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: The papers presented make up a multi-viewpoint case study of the role played by analysis in the formulation of cable television regulatory policy. It is a contribution to the literature on the influence of analysis on decisions reached in complex political environemtns.

The Role of Analysis in Regulatory Decisionmaking

Author : Rolla Edward Park
Publisher :
ISBN 13 :
Total Pages : 136 pages
Book Rating : 4.3/5 (97 download)

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Book Synopsis The Role of Analysis in Regulatory Decisionmaking by : Rolla Edward Park

Download or read book The Role of Analysis in Regulatory Decisionmaking written by Rolla Edward Park and published by . This book was released on 1973 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309172802
Total Pages : 88 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making by : Institute of Medicine

Download or read book Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making written by Institute of Medicine and published by National Academies Press. This book was released on 1999-07-27 with total page 88 pages. Available in PDF, EPUB and Kindle. Book excerpt: In an effort to increase knowledge and understanding of the process of assuring data quality and validity in clinical trials, the IOM hosted a workshop to open a dialogue on the process to identify and discuss issues of mutual concern among industry, regulators, payers, and consumers. The presenters and panelists together developed strategies that could be used to address the issues that were identified. This IOM report of the workshop summarizes the present status and highlights possible strategies for making improvements to the education of interested and affected parties as well as facilitating future planning.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309218160
Total Pages : 292 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Ethical and Scientific Issues in Studying the Safety of Approved Drugs by : Institute of Medicine

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.

Regulation and Regulatory Processes

Author : Cary Coglianese
Publisher : Ashgate Publishing
ISBN 13 : 9780754625186
Total Pages : 0 pages
Book Rating : 4.6/5 (251 download)

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Book Synopsis Regulation and Regulatory Processes by : Cary Coglianese

Download or read book Regulation and Regulatory Processes written by Cary Coglianese and published by Ashgate Publishing. This book was released on 2007 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: As the ever-proliferating rules and enforcement agents of the regulatory state have become increasingly central to contemporary legal systems, they have drawn the close attention of sociolegal scholars who seek to illuminate how regulation actually functions. This volume includes some of the most insightful empirical studies of regulation, both in the United States and in other advanced democratic economies. The articles address the politics of regulatory policymaking and the design of regulatory agencies; patterns of implementation and enforcement; and business responses to regulatory goals and requirements.

Reinventing Rationality

Author : Thomas O. McGarity
Publisher : Cambridge University Press
ISBN 13 : 0521402565
Total Pages : 405 pages
Book Rating : 4.5/5 (214 download)

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Book Synopsis Reinventing Rationality by : Thomas O. McGarity

Download or read book Reinventing Rationality written by Thomas O. McGarity and published by Cambridge University Press. This book was released on 1991-05-31 with total page 405 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this book, Professor McGarity reveals the complex and problematic relationship between the 'regulatory reform' movements initiated in the early l970s and the United States' federal bureaucracy. Examining both the theory and application of 'regulatory reform' under the Reagan administration, the author succeeds in offering both a relevant analysis and critique of 'regulatory reform' and its implementation through bureaucratic channels. Using several case studies from the early Reagan years, this book describes the clash of regulatory cultures resulting from the President's attempt to incorporate 'regulatory analysis' into the bureaucratic decision-making process. Yet while McGarity recognizes the limitations of regulatory analysis, he concludes with suggestions for enhancing its effectiveness. This book could be used not only as a textbook for political science and government courses but also for graduate applications in public policy and public administration.

Models in Environmental Regulatory Decision Making

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309178924
Total Pages : 286 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Models in Environmental Regulatory Decision Making by : National Research Council

Download or read book Models in Environmental Regulatory Decision Making written by National Research Council and published by National Academies Press. This book was released on 2007-07-25 with total page 286 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many regulations issued by the U.S. Environmental Protection Agency (EPA) are based on the results of computer models. Models help EPA explain environmental phenomena in settings where direct observations are limited or unavailable, and anticipate the effects of agency policies on the environment, human health and the economy. Given the critical role played by models, the EPA asked the National Research Council to assess scientific issues related to the agency's selection and use of models in its decisions. The book recommends a series of guidelines and principles for improving agency models and decision-making processes. The centerpiece of the book's recommended vision is a life-cycle approach to model evaluation which includes peer review, corroboration of results, and other activities. This will enhance the agency's ability to respond to requirements from a 2001 law on information quality and improve policy development and implementation.

Risk Analysis and Governance in EU Policy Making and Regulation

Author : Bernardo Delogu
Publisher : Springer
ISBN 13 : 331930822X
Total Pages : 298 pages
Book Rating : 4.3/5 (193 download)

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Book Synopsis Risk Analysis and Governance in EU Policy Making and Regulation by : Bernardo Delogu

Download or read book Risk Analysis and Governance in EU Policy Making and Regulation written by Bernardo Delogu and published by Springer. This book was released on 2016-05-02 with total page 298 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an easy, but comprehensive and rigorous access to the main concepts, terminology, methods and procedures of risk analysis intended for all those involved in the EU policy and regulatory decision making on risks. It establishes a common ground of knowledge which enables a more informed dialogue on risks, a closer collaboration between decision makers and scientists and a better appraisal of the potential and limits of risk science. The book also brings together in an accessible way much multidisciplinary knowledge which had been dispersed over many technical documents and specialist books. The EU is in the front line of health, safety and environmental risk management. GMOs, food safety, hazardous chemicals, climate change, radiation hazards, are just a few of the popular risk issues addressed by the EU through policy and regulatory measures. The risk analysis paradigm, including risk assessment, management and communication has been at the core of the EU decision making for a long time already. EU Institutions strive for a science-based approach to risk management. Nevertheless, the dialogue and collaboration on risk issues between policy makers, stakeholders and scientists are still difficult and the potential and limits of science in support of decision making, as well as the basic concepts of risk analysis are not fully understood outside the narrow specialist circles.

Valuing Health for Regulatory Cost-Effectiveness Analysis

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309164842
Total Pages : 382 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Valuing Health for Regulatory Cost-Effectiveness Analysis by : Institute of Medicine

Download or read book Valuing Health for Regulatory Cost-Effectiveness Analysis written by Institute of Medicine and published by National Academies Press. This book was released on 2006-04-28 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promoting human health and safety by reducing exposures to risks and harms through regulatory interventions is among the most important responsibilities of the government. Such efforts encompass a wide array of activities in many different contexts: improving air and water quality; safeguarding the food supply; reducing the risk of injury on the job, in transportation, and from consumer products; and minimizing exposure to toxic chemicals. Estimating the magnitude of the expected health and longevity benefits and reductions in mortality, morbidity, and injury risks helps policy makers decide whether particular interventions merit the expected costs associated with achieving these benefits and inform their choices among alternative strategies. Valuing Health for Regulatory Cost-Effectiveness Analysis provides useful recommendations for how to measure health-related quality of- life impacts for diverse public health, safety, and environmental regulations. Public decision makers, regulatory analysts, scholars, and students in the field will find this an essential review text. It will become a standard reference for all government agencies and those consultants and contractors who support the work of regulatory programs.

Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309310032
Total Pages : 150 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products by : Institute of Medicine

Download or read book Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products written by Institute of Medicine and published by National Academies Press. This book was released on 2014-12-19 with total page 150 pages. Available in PDF, EPUB and Kindle. Book excerpt: Despite the extensive body of evidence that informs regulatory decisions on pharmaceutical products, significant uncertainties persist, including the underlying variability in human biology, factors associated with the chemistry of a drug, and limitations in the research and clinical trial process itself that might limit the generalizability of results. As a result, regulatory reviewers are consistently required to draw conclusions about a drug's safety and efficacy from imperfect data. Efforts are underway within the drug development community to enhance the evaluation and communication of the benefits and risks associated with pharmaceutical products, aimed at increasing the predictability, transparency, and efficiency of pharmaceutical regulatory decision making. Effectively communicating regulatory decisions necessarily includes explanation of the impact of uncertainty on decision making. On February 12 and May 12, 2014, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation held public workshops to advance the development of more systematic and structured approaches to characterize and communicate the sources of uncertainty in the assessment of benefits and risks, and to consider their implications for pharmaceutical regulatory decisions. Workshop presentations and discussions on February 12 were convened to explore the science of identifying and characterizing uncertainty in scientific evidence and approaches to translate uncertainties into decisions that reflect the values of stakeholders. The May 12 workshop presentations and discussions explored tools and approaches to communicating about scientific uncertainties to a range of stakeholders in the drug development process. Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products summarizes the presentation and discussion of both events. This report explores potential analytical and communication approaches and identifies key considerations on their development, evaluation, and incorporation into pharmaceutical benefit- risk assessment throughout the entire drug development lifecycle.

Science and Decisions

Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309120462
Total Pages : 422 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Science and Decisions by : National Research Council

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.

Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309222176
Total Pages : 118 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development by : Institute of Medicine

Download or read book Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development written by Institute of Medicine and published by National Academies Press. This book was released on 2012-04-04 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

Preparing for Future Products of Biotechnology

Author : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309452058
Total Pages : 231 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis Preparing for Future Products of Biotechnology by : National Academies of Sciences, Engineering, and Medicine

Download or read book Preparing for Future Products of Biotechnology written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-07-28 with total page 231 pages. Available in PDF, EPUB and Kindle. Book excerpt: Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5â€"10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology? Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

Portfolio Decision Analysis

Author : Ahti Salo
Publisher : Springer Science & Business Media
ISBN 13 : 9781441999436
Total Pages : 409 pages
Book Rating : 4.9/5 (994 download)

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Book Synopsis Portfolio Decision Analysis by : Ahti Salo

Download or read book Portfolio Decision Analysis written by Ahti Salo and published by Springer Science & Business Media. This book was released on 2011-08-12 with total page 409 pages. Available in PDF, EPUB and Kindle. Book excerpt: Portfolio Decision Analysis: Improved Methods for Resource Allocation provides an extensive, up-to-date coverage of decision analytic methods which help firms and public organizations allocate resources to 'lumpy' investment opportunities while explicitly recognizing relevant financial and non-financial evaluation criteria and the presence of alternative investment opportunities. In particular, it discusses the evolution of these methods, presents new methodological advances and illustrates their use across several application domains. The book offers a many-faceted treatment of portfolio decision analysis (PDA). Among other things, it (i) synthesizes the state-of-play in PDA, (ii) describes novel methodologies, (iii) fosters the deployment of these methodologies, and (iv) contributes to the strengthening of research on PDA. Portfolio problems are widely regarded as the single most important application context of decision analysis, and, with its extensive and unique coverage of these problems, this book is a much-needed addition to the literature. The book also presents innovative treatments of new methodological approaches and their uses in applications. The intended audience consists of practitioners and researchers who wish to gain a good understanding of portfolio decision analysis and insights into how PDA methods can be leveraged in different application contexts. The book can also be employed in courses at the post-graduate level.

Does Regulation Kill Jobs?

Author : Cary Coglianese
Publisher : University of Pennsylvania Press
ISBN 13 : 0812209249
Total Pages : 299 pages
Book Rating : 4.8/5 (122 download)

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Book Synopsis Does Regulation Kill Jobs? by : Cary Coglianese

Download or read book Does Regulation Kill Jobs? written by Cary Coglianese and published by University of Pennsylvania Press. This book was released on 2014-01-06 with total page 299 pages. Available in PDF, EPUB and Kindle. Book excerpt: As millions of Americans struggle to find work in the wake of the Great Recession, politicians from both parties look to regulation in search of an economic cure. Some claim that burdensome regulations undermine private sector competitiveness and job growth, while others argue that tough new regulations actually create jobs at the same time that they provide other benefits. Does Regulation Kill Jobs? reveals the complex reality of regulation that supports neither partisan view. Leading legal scholars, economists, political scientists, and policy analysts show that individual regulations can at times induce employment shifts across firms, sectors, and regions—but regulation overall is neither a prime job killer nor a key job creator. The challenge for policymakers is to look carefully at individual regulatory proposals to discern any job shifting they may cause and then to make regulatory decisions sensitive to anticipated employment effects. Drawing on their analyses, contributors recommend methods for obtaining better estimates of job impacts when evaluating regulatory costs and benefits. They also assess possible ways of reforming regulatory institutions and processes to take better account of employment effects in policy decision-making. Does Regulation Kills Jobs? tackles what has become a heated partisan issue with exactly the kind of careful analysis policymakers need in order to make better policy decisions, providing insights that will benefit both politicians and citizens who seek economic growth as well as the protection of public health and safety, financial security, environmental sustainability, and other civic goals. Contributors: Matthew D. Adler, Joseph E. Aldy, Christopher Carrigan, Cary Coglianese, E. Donald Elliott, Rolf Färe, Ann Ferris, Adam M. Finkel, Wayne B. Gray, Shawna Grosskopf, Michael A. Livermore, Brian F. Mannix, Jonathan S. Masur, Al McGartland, Richard Morgenstern, Carl A. Pasurka, Jr., William A. Pizer, Eric A. Posner, Lisa A. Robinson, Jason A. Schwartz, Ronald J. Shadbegian, Stuart Shapiro.

International Regulatory Harmonization Amid Globalization of Drug Development

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309284791
Total Pages : 129 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis International Regulatory Harmonization Amid Globalization of Drug Development by : Institute of Medicine

Download or read book International Regulatory Harmonization Amid Globalization of Drug Development written by Institute of Medicine and published by National Academies Press. This book was released on 2013-11-24 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health. To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.