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.

This Safety Guide provides recommendations on meeting the requirements of IAEA Safety Standards Series No. GSR Part 1 (Rev. 1), Governmental, Legal and Regulatory Framework for Safety, on the regulatory body's core functions and associated regulatory processes. This guidance is particularly important for regulatory bodies having responsibilities covering a range of facilities and activities that give rise to radiation risks and the important organizational interfaces between various regulatory authorities, which require effective coordination and cooperation. It promotes a consistent approach to regulation and specifically addresses the release of facilities and activities from regulatory control including sites, buildings, equipment and material. The publication is intended to be used mainly by regulatory bodies but will also be useful for governments that are developing a regulatory framework for safety. It will also assist authorized parties and others dealing with radiation sources in understanding regulatory procedures, processes and expectations.

This Second Edition examines the mechanisms and means to establish regulatory compliance for pharmaceutical products and company practices. It focuses on major legislative revisions that impact requirements for drug safety reviews, product regulatory approvals, and marketing practices. Written by top industry professionals, practicing attorneys, an

Regulation has become a front-page topic recently, often referenced by politicians in conjunction with the current state of the U.S. economy. Yet despite regulation’s increased presence in current politics and media, The Politics of Regulatory Reform argues that the regulatory process and its influence on the economy is misunderstood by the general public as well as by many politicians. In this book, two experienced regulation scholars confront questions relevant to both academic scholars and those with a general interest in ascertaining the effects and importance of regulation. How does regulation impact the economy? What roles do politicians play in making regulatory decisions? Why do politicians enact laws that require regulations and then try to hamper agencies abilities to issue those same regulations? The authors answer these questions and untangle the misperceptions behind regulation by using an area of regulatory policy that has been underutilized until now. Rather than focusing on the federal government, Shapiro and Borie-Holtz have gathered a unique dataset on the regulatory process and output in the United States. They use state-specific data from twenty-eight states, as well as a series of case studies on regulatory reform, to question widespread impressions and ideas about the regulatory process. The result is an incisive and comprehensive study of the relationship between politics and regulation that also encompasses the effects of regulation and the reasons why regulatory reforms are enacted.

An in-depth look at the institutionalization of alternative dispute resolution (ADR) processes in the federal and state regulatory arenas over the past twenty-five years, this volume showcases the value of these processes and highlights the potential for their expanded application and growth. It describes ADR techniques, how to use them, and how to integrate them into existing processes, using examples from the Federal Energy Regulatory Commission and three state utility regulatory commissions. The book recounts ADR successes, recognizing that traditional litigative methods may not always meet the needs of agencies, the parties, or the public. Institutionalizing these processes requires a systematic commitment to different approaches to problem-solving and, ultimately, cultural change. The authors spearheaded initiatives to integrate these processes and skills at the federal level. Drawing from valuable insights gained from their experience, the authors introduce a versatile new ADR system design model, the Voices of Value, which aims to enhance input, creativity, and effectiveness in regulatory and other public arenas as well as the private sector.

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.