Achieving Regulatory Excellence

Whether striving to protect citizens from financial risks, climate change, inadequate health care, or the uncertainties of the emerging “sharing” economy, regulators must routinely make difficult judgment calls in an effort to meet the conflicting demands that society places on them. Operating within a political climate of competing demands, regulators need a lodestar to help them define and evaluate success. Achieving Regulatory Excellence provides that direction by offering new insights from law, public administration, political science, sociology, and policy sciences on what regulators need to do to improve their performance. Achieving Regulatory Excellence offers guidance from leading international experts about how regulators can set appropriate priorities and make sound, evidence-based decisions through processes that are transparent and participatory. With increasing demands for smarter but leaner government, the need for sound regulatory capacity—for regulatory excellence—has never been stronger.

Whether striving to protect citizens from financial risks, climate change, inadequate health care, or the uncertainties of the emerging “sharing” economy, regulators must routinely make difficult judgment calls in an effort to meet the conflicting demands that society places on them. Operating within a political climate of competing demands, regulators need a lodestar to help them define and evaluate success. Achieving Regulatory Excellence provides that direction by offering new insights from law, public administration, political science, sociology, and policy sciences on what regulators need to do to improve their performance. Achieving Regulatory Excellence offers guidance from leading international experts about how regulators can set appropriate priorities and make sound, evidence-based decisions through processes that are transparent and participatory. With increasing demands for smarter but leaner government, the need for sound regulatory capacity—for regulatory excellence—has never been stronger. In addition to chapters by editor Cary Coglianese, and a foreword by Jim Ellis, president and chief executive officer of the Alberta Energy Regulator, contributors include Robert Baldwin (London School of Economics and Political Science), John Braithwaite (Australian National University), Angus Corbett (University of Pennsylvania), Daniel Esty (Yale University), Adam Finkel (University of Pennsylvania and University of Michigan), Ted Gayer (Brookings Institution), John Graham (Indiana University), Neil Gunningham (Australian National University), Kathryn Harrison (University of British Columbia), Bridget Hutter (London School of Economics and Political Science), Howard Kunreuther (Wharton School at the University of Pennsylvania), David Levi-Faur (Hebrew University of Jerusalem), Shelley H. Metzenbaum (Volcker Alliance), Donald P. Moynihan (University of Wisconsin–Madison), Paul R. Noe (American Forest and Paper Association), Gaurav Vasisht (Volcker Alliance), David Vogel (University of California–Berkeley), and Wendy Wagner (University of Texas School of Law).

Tobacco companies had been protecting their turf for decades. They had congressmen in their pocket. They had corrupt scientists who made excuses about nicotine, cancer and addiction. They had hordes of lawyers to threaten anyone -- inside the industry or out -- who posed a problem. They had a whole lot of money to spend. And they were good at getting people to do what they wanted them to do. After all, they had already convinced millions of Americans to take up an addictive, unhealthy, and potentially deadly habit. David Kessler didn't care about all that. In this book he tells for the first time the thrilling detective story of how the underdog FDA -- while safeguarding the nation's food, drugs, and blood supply -- finally decided to take on one of the world's most powerful opponents, and how it won. Like A Civil Action or And the Band Played On, A Question of Intent weaves together science, law, and fascinating characters to tell an important and often unexpectedly moving story. We follow Kessler's team of investigators as they race to find the clues that will allow the FDA to assert jurisdiction over cigarettes, while the tobacco companies and their lawyers fight back -- hard. Full of insider information and drama, told with wit, and animated by its author's moral passion, A Question of Intent reads like a Grisham thriller, with one exception -- everything in it is true.

This book transcends current debate on government regulation by lucidly outlining how regulations can be a fruitful combination of persuasion and sanctions. The regulation of business by the United States government is often ineffective despite being more adversarial in tone than in other nations. The authors draw on both empirical studies of regulation from around the world and modern game theory to illustrate innovative solutions to this problem. Their ideas include an argument for the empowerment of private and public interest groups in the regulatory process and a provocative discussion of how the government can support and encourage industry self-regulation.

AAP Prose Award Finalist 2018/19 Management of Animal Care and Use Programs in Research, Education, and Testing, Second Edition is the extensively expanded revision of the popular Management of Laboratory Animal Care and Use Programs book published earlier this century. Following in the footsteps of the first edition, this revision serves as a first line management resource, providing for strong advocacy for advancing quality animal welfare and science worldwide, and continues as a valuable seminal reference for those engaged in all types of programs involving animal care and use. The new edition has more than doubled the number of chapters in the original volume to present a more comprehensive overview of the current breadth and depth of the field with applicability to an international audience. Readers are provided with the latest information and resource and reference material from authors who are noted experts in their field. The book: - Emphasizes the importance of developing a collaborative culture of care within an animal care and use program and provides information about how behavioral management through animal training can play an integral role in a veterinary health program - Provides a new section on Environment and Housing, containing chapters that focus on management considerations of housing and enrichment delineated by species - Expands coverage of regulatory oversight and compliance, assessment, and assurance issues and processes, including a greater discussion of globalization and harmonizing cultural and regulatory issues - Includes more in-depth treatment throughout the book of critical topics in program management, physical plant, animal health, and husbandry. Biomedical research using animals requires administrators and managers who are knowledgeable and highly skilled. They must adapt to the complexity of rapidly-changing technologies, balance research goals with a thorough understanding of regulatory requirements and guidelines, and know how to work with a multi-generational, multi-cultural workforce. This book is the ideal resource for these professionals. It also serves as an indispensable resource text for certification exams and credentialing boards for a multitude of professional societies Co-publishers on the second edition are: ACLAM (American College of Laboratory Animal Medicine); ECLAM (European College of Laboratory Animal Medicine); IACLAM (International Colleges of Laboratory Animal Medicine); JCLAM (Japanese College of Laboratory Animal Medicine); KCLAM (Korean College of Laboratory Animal Medicine); CALAS (Canadian Association of Laboratory Animal Medicine); LAMA (Laboratory Animal Management Association); and IAT (Institute of Animal Technology).

Featuring case studies and discussion questions, this textbook – with revisions addressing significant changes to US food law – offers accessible coverage appropriate to a wide audience of students and professionals. Overviews the federal statutes, regulations, and regulatory agencies concerned with food regulation and introduces students to the case law and statutory scheme of food regulation Focuses updated content on the 2011 FDA Food Safety Modernization Act (FSMA), the biggest change to US food law since the 1930s Contains over 20% new material, particularly a rewritten import law chapter and revisions related to food safety regulation, health claims, and food defense Features case studies and discussion questions about application of law, policy questions, and emerging issues

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.

In this sprawling and ambitious book John Braithwaite successfully manages to link the contemporary dynamics of macro political economy to the dynamics of citizen engagement and organisational activism at the micro intestacies of governance practices. This is no mean feat and the logic works. . . Stephen Bell, The Australian Journal of Public Administration Everyone who is puzzled by modern regulocracy should read this book. Short and incisive, it represents the culmination of over twenty years work on the subject. It offers us a perceptive and wide-ranging perspective on the global development of regulatory capitalism and an important analysis of points of leverage for democrats and reformers. Christopher Hood, All Souls College, Oxford, UK It takes a great mind to produce a book that is indispensable for beginners and experts, theorists and policymakers alike. With characteristic clarity, admirable brevity, and his inimitable mix of description and prescription, John Braithwaite explains how corporations and states regulate each other in the complex global system dubbed regulatory capitalism. For Braithwaite aficionados, Regulatory Capitalism brings into focus the big picture created from years of meticulous research. For Braithwaite novices, it is a reading guide that cannot fail to inspire them to learn more. Carol A. Heimer, Northwestern University, US Reading Regulatory Capitalism is like opening your eyes. John Braithwaite brings together law, politics, and economics to give us a map and a vocabulary for the world we actually see all around us. He weaves together elements of over a decade of scholarship on the nature of the state, regulation, industrial organization, and intellectual property in an elegant, readable, and indispensable volume. Anne-Marie Slaughter, Princeton University, US Encyclopedic in scope, chock full of provocative even jarring claims, Regulatory Capitalism shows John Braithwaite at his transcendental best. Ian Ayres, Yale Law School, Yale University, US Contemporary societies have more vibrant markets than past ones. Yet they are more heavily populated by private and public regulators. This book explores the features of such a regulatory capitalism, its tendencies to be cyclically crisis-ridden, ritualistic and governed through networks. New ways of thinking about resultant policy challenges are developed. At the heart of this latest work by John Braithwaite lies the insight by David Levi-Faur and Jacint Jordana that the welfare state was succeeded in the 1970s by regulatory capitalism. The book argues that this has produced stronger markets, public regulation, private regulation and hybrid private/public regulation as well as new challenges such as a more cyclical quality to crises of market and governance failure, regulatory ritualism and markets in vice. However, regulatory capitalism also creates opportunities for better design of markets in virtue such as markets in continuous improvement, privatized enforcement of regulation, open source business models, regulatory pyramids with networked escalation and meta-governance of justice. Regulatory Capitalism will be warmly welcomed by regulatory scholars in political science, sociology, history, economics, business schools and law schools as well as regulatory bureaucrats, policy thinkers in government and law and society scholars.