The book is a good read due to its well-integrated form, its comparative approach, its empirical case descriptions and its ability to encourage readers to approach the field of regulatory innovation. Estrid Sørensen, Science Studies Much hype has been generated about the importance of innovation for public and private sector organisations. Regulatory Innovation offers the first detailed study of regulatory innovation in a multiplicity of countries and domains. This book draws on in-depth studies of innovation in regulatory instruments and practices across high- and low-technology sectors, across different countries and from the early to the late 20th century. Highlighting different worlds of regulatory innovation those of the individual, the organization, the state, the global polity, and innovation itself, this book offers a fresh perspective and valuable insights for the practice and study of regulatory innovation. The explicit comparative focus of the case studies and the worlds of regulatory innovation approach make this book essential reading for academic researchers and students interested in regulation.

From social media to mortgage-backed securities, innovation carries both risk and opportunity. Groups of people win, and lose, when innovation changes the ground rules. Looking beyond formal politics, this new book by Cristie Ford argues that we need to recognize innovation, and financial innovation in particular, as a central challenge for regulation. Regulation is at the leading edge of politics and policy in ways that we have not yet fully grasped. Seemingly innocuous regulatory design choices have clear and profound practical ramifications for many of our most cherished social commitments. Innovation is a complex phenomenon that needs to be understood not only in technical terms, but also in human ones. Using financial regulation as her primary example, Ford argues for a fresh approach to regulation, which recognizes innovation for the regulatory challenge that it is, and which binds our cherished social values and our regulatory tools ever more tightly together.

A detailed analysis of the ethical, legal, and regulatory landscape of medical devices in the US and EU.

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.

The Food and Drug Administration (FDA) is responsible for assuring that medical devices are safe and effective before they go on the market. As part of its assessment of FDA's premarket clearance process for medical devices, the IOM held a workshop June 14-15 to discuss how to best balance patient safety and technological innovation. This document summarizes the workshop.

Environmental regulation has come of age in recent decades as the blunt methods of command-and-control have been subjected to trenchant criticism from both economists and lawyers in the United States and Europe. As a result of this intellectual development, as well as continuing and increasing severity of environmental problems, there is a need for fresh thinking about regulatory methods that are rational from both economic and legal points of view. This book focuses on the viability of one particular regulatory innovation--the use of agreements or contracts for environmental regulation--as it has been practised in the United States and Europe. The various contributions explore the general idea that certain kinds of environmental problems may best be addressed through contracts among interested parties, including representatives of various levels of government, business, local community and employment representatives, and public interest groups. The parties get together to discuss a particular problem and then agree to an agreement or contract designed to address key issues and interests. At least in some situations, this approach may yield greater flexibility, stronger commitment, and more creative outcomes than traditional command-and-control regulation. Experiments in the use of environmental contracts have begun on both sides of the Atlantic, a fact which makes the comparative study offered here especially timely and valuable.

Instant, or fast, payments are credit transfers completed and settled within seconds or minutes. They have low costs, reduce payment risk, and have significantly replaced the use of cash, cards, or check and direct debit payments. We note the role played by regulators in promoting instant payments and identify instances of significant payment instrument substitution across 12 advanced and emerging market economies. This substitution reflects the realized demand for attributes offered by instant payments. As these attributes are quite similar to those for CBDC, the demand for retail CBDC (if issued) may be less compelling.

Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

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.

Advances in agricultural genomics could help address pressing global issues, such as world hunger, by improving crop yield. However, overlap and conflict in intellectual property and biosafety regimes – known collectively as the “Intellectual Property–Regulatory Complex” – create significant barriers to innovation. In this collection, leading legal, policy, and economics experts analyze the impact of the Complex on agricultural genomics. They reveal how it impacts scientific advancement in ways that are underappreciated when intellectual property and biosafety regimes are examined in isolation. After identifying how the interplay between multiple regimes impedes research, development, and product distribution, they propose solutions that would further the aims of the current intellectual property and biosafety regimes while enabling growth and innovation in agricultural genomics.