Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development
Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-04-04

Total Pages: 118

ISBN-13: 0309222176

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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.

Does Regulation Kill Jobs?
Does Regulation Kill Jobs?

Author: Cary Coglianese

Publisher: University of Pennsylvania Press

Published: 2014-01-06

Total Pages: 299

ISBN-13: 0812209249

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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.

Regulation
Regulation

Author: Jerry Brito

Publisher: Mercatus Center at George Mason University

Published: 2012-08-13

Total Pages: 128

ISBN-13: 0983607737

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Federal regulations affect nearly every area of our lives and interest in them is increasing. However, many people have no idea how regulations are developed or how they have an impact on our lives. Regulation: A Primer by Susan Dudley and Jerry Brito provides an accessible overview of regulatory theory, analysis, and practice. The Primer examines the constitutional underpinnings of federal regulation and discusses who writes and enforces regulation and how they do it. Published by the Mercatus Center at George Mason University, it also provides insights into the different varieties of regulation and how to analyze whether a regulatory proposal makes citizens better or worse off. Each chapter discusses key aspects of regulation and provides further readings for those interested in exploring these topics in more detail.

Government and Markets
Government and Markets

Author: Edward J. Balleisen

Publisher: Cambridge University Press

Published: 2010

Total Pages: 579

ISBN-13: 0521118484

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After two generations of emphasis on governmental inefficiency and the need for deregulation, we now see growing interest in the possibility of constructive governance, alongside public calls for new, smarter regulation. Yet there is a real danger that regulatory reforms will be rooted in outdated ideas. As the financial crisis has shown, neither traditional market failure models nor public choice theory, by themselves, sufficiently inform or explain our current regulatory challenges. Regulatory studies, long neglected in an atmosphere focused on deregulatory work, is in critical need of new models and theories that can guide effective policy-making. This interdisciplinary volume points the way toward the modernization of regulatory theory. Its essays by leading scholars move past predominant approaches, integrating the latest research about the interplay between human behavior, societal needs, and regulatory institutions. The book concludes by setting out a potential research agenda for the social sciences.

New Perspectives on Regulation
New Perspectives on Regulation

Author: David A. Moss

Publisher: The Tobin Project

Published: 2009

Total Pages: 169

ISBN-13: 0982478801

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As an experiment in reconnecting academia to the broader democracy, this work is designed to invigorate public policy debate by rededicating academic work to the pursuit of solutions to society's great problems.

Ethics and Regulation of Clinical Research
Ethics and Regulation of Clinical Research

Author: Robert J. Levine

Publisher: Yale University Press

Published: 1988-01-01

Total Pages: 484

ISBN-13: 9780300042887

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The use of human subjects in medical and scientific research has given rise to troubling ethical questions. How should human subjects be selected for experiments? What should they be told about the research in which they are involved? How can their privacy be protected? When is it permissible to deceive them? How do we deal with subjects such as children, fetuses, and the mentally infirm, for whom informed consent is impossible? In this book, Dr. Robert J. Levine reviews federal regulations, ethical analysis, and case studies in an attempt to answer these questions. His book is an essential reference for everyone--members of institutional review boards, scientists, philosophers, lawyers--addressing the ethical issues involved. "[Levine's] experience as a clinician, IRB chairman, writer and editor of a journal devoted exclusively to issues faced by IRBS makes him uniquely qualified to bring together the legal, ethical, and practical dimensions. . . [The book] is sophisticated but readable. . . [and] should be on every IRB administrator's desk and in every medical ethics library."--Norman Fost, M.D., The New England Journal of Medicine "Levine. . . is one of the foremost historians of contemporary clinical science. . . . His book is at once a guide to primary sources for the history of clinical research in the late twentieth century and a pioneering secondary source about that history."--Daniel M. Fox, Bulletin of the History of Medicine "You will be charmed by the [book's] elegance and lucidity and. . . persuaded of its relevance to doctors in any country."--Alex Paton, British Medical Journal "Should be of wide interest to those keen to see advances in medical research brought into general medical practice."--Gilbert Omenn, Issues in Science and Technology

Economic Regulation and Its Reform
Economic Regulation and Its Reform

Author: Nancy L. Rose

Publisher: University of Chicago Press

Published: 2014-08-29

Total Pages: 619

ISBN-13: 022613816X

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The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy.

Studies in Public Regulation
Studies in Public Regulation

Author: Gary Fromm

Publisher: MIT Press

Published: 1983

Total Pages: 418

ISBN-13: 9780262560283

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"This is a stimulating collection.... Each [paper] makes an original contribution to some aspect of the economics of regulation. " Contributors Paul L. Joskow, Roger G. Noll, Robert D. Willig, Elizabeth E. Bailey, Patricia Munch, Dennis Smallwood, Richard C. Levin, Robert A. Leone, John E. Jackson, Melvyn A. Fuss, Leonard Waverman, Kenneth C. Baseman, and Sam Peltzman A Regulation of Economic Activity series paperback.

Regulatory Breakdown
Regulatory Breakdown

Author: Cary Coglianese

Publisher: University of Pennsylvania Press

Published: 2012-08-16

Total Pages: 290

ISBN-13: 0812207491

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Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation brings fresh insight and analytic rigor to what has become one of the most contested domains of American domestic politics. Critics from the left blame lax regulation for the housing meltdown and financial crisis—not to mention major public health disasters ranging from the Gulf Coast oil spill to the Upper Big Branch Mine explosion. At the same time, critics on the right disparage an excessively strict and costly regulatory system for hampering economic recovery. With such polarized accounts of regulation and its performance, the nation needs now more than ever the kind of dispassionate, rigorous scholarship found in this book. With chapters written by some of the nation's foremost economists, political scientists, and legal scholars, Regulatory Breakdown brings clarity to the heated debate over regulation by dissecting the disparate causes of the current crisis as well as analyzing promising solutions to what ails the U.S. regulatory system. This volume shows policymakers, researchers, and the public why they need to question conventional wisdom about regulation—whether from the left or the right—and demonstrates the value of undertaking systematic analysis before adopting policy reforms in the wake of disaster.

Preventing Regulatory Capture
Preventing Regulatory Capture

Author: Daniel Carpenter

Publisher: Cambridge University Press

Published: 2014

Total Pages: 531

ISBN-13: 1107036089

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Leading scholars from across the social sciences present empirical evidence that the obstacle of regulatory capture is more surmountable than previously thought.