Download Free Regulatory Innovation Center Book in PDF and EPUB Free Download. You can read online Regulatory Innovation Center and write the review.

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.
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.
The Regulatory Craft tackles one of the most pressing public policy issues of our time—the reform of regulatory and enforcement practice. Malcolm K. Sparrow shows how the vogue prescriptions for reform (centered on concepts of customer service and process improvement) fail to take account of the distinctive character of regulatory responsibilities—which involve the delivery of obligations rather than just services.In order to construct more balanced prescriptions for reform, Sparrow invites us to reconsider the central purpose of social regulation—the abatement or control of risks to society. He recounts the experiences of pioneering agencies that have confronted the risk-control challenge directly, developing operational capacities for specifying risk-concentrations, problem areas, or patterns of noncompliance, and then designing interventions tailored to each problem. At the heart of a new regulatory craftsmanship, according to Sparrow, lies the central notion, "pick important problems and fix them." This beguilingly simple idea turns out to present enormously complex implementation challenges and carries with it profound consequences for the way regulators organize their work, manage their discretion, and report their performance. Although the book is primarily aimed at regulatory and law-enforcement practitioners, it will also be invaluable for legislators, overseers, and others who care about the nature and quality of regulatory practice, and who want to know what kind of performance to demand from regulators and how it might be delivered. It stresses the enormous benefit to society that might accrue from development of the risk-control art as a core professional skill for regulators.
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.
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.
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.
This ground-breaking book addresses the challenge of regulatory delivery, defined as the way that regulatory agencies operate in practice to achieve the intended outcomes of regulation. Regulatory reform is moving beyond the design of regulation to address what good regulatory delivery looks like. The challenge in practice is to operate a regulatory regime that is both appropriate and effective. Questions of how regulations are received and applied by those whose behaviour they seek to control, and the way they are enforced, are vital in securing desired regulatory outcomes. This book, written by and for practitioners of regulatory delivery, explains the Regulatory Delivery Model, developed by Graham Russell and his team at the UK Department for Business, Energy and Industrial Strategy. The model sets out a framework to steer improvements to regulatory delivery, comprising three prerequisites for regulatory agencies to be able to operate effectively (Governance Frameworks, Accountability and Culture) and three practices for regulatory agencies to be able to deliver societal outcomes (Outcome Measurement, Risk-based Prioritisation and Intervention Choices). These elements are explored by an international group of experts in regulatory delivery reform, with case studies from around the world. Regulatory Delivery is the first product of members of the International Network for Delivery of 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.
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.
Will innovators be forced to seek the blessing of public officials before they develop and deploy new devices and services, or will they be generally left free to experiment with new technologies and business models? In this book, Adam Thierer argues that if the former disposition, “the precautionary principle,” trumps the latter, “permissionless innovation,” the result will be fewer services, lower-quality goods, higher prices, diminished economic growth, and a decline in the overall standard of living. When public policy is shaped by “precautionary principle” reasoning, it poses a serious threat to technological progress, economic entrepreneurialism, and long-run prosperity. By contrast, permissionless innovation has fueled the success of the Internet and much of the modern tech economy in recent years, and it is set to power the next great industrial revolution—if we let it.