Download or read book A Practical Guide to FDA s Food and Drug Law and Regulation Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Download or read book Medical Devices Law and Regulation Answer Book written by Susan Onel and published by . This book was released on 2016-11 with total page 1112 pages. Available in PDF, EPUB and Kindle. Book excerpt: This title walks you through the current regulatory requirements and provides in-depth coverage of individual FDA programs that cover everything from conducting clinical trials, preparing successful premarket submissions, adhering to quality system requirements, and fulfilling post-market obligations.
Download or read book Expertise in Regulation and Law written by Gary Edmond and published by Routledge. This book was released on 2017-07-05 with total page 340 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection of essays examines the multi-faceted roles of experts and expertise in and around contemporary legal and regulatory cultures. The essays illustrate the complexity intrinsic to the production and use of expert knowledge, particularly during transition from specialist communities to other domains such as policy formulation, regulatory standard setting and litigation. Several themes pervade the collection. These include the need to recognize that: expert knowledge and opinion is often complex, controversial and contested; there are no simple criteria for resolving disagreements between experts; appeals to 'objectivity' and 'impartiality' tend to be rhetorical rather than analytical; contests in expertise are frequently episodes in larger campaigns; there are many different models of expertise and knowledge; processes designed to deal with expert knowledge are unavoidably political; questions around who is an expert and what should count as expertise are not always self-evident; and the evidence rarely 'speaks for itself'.
Download or read book Food Regulation written by Neal D. Fortin and published by John Wiley & Sons. This book was released on 2016-10-25 with total page 1028 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Download or read book Law as Punishment Law as Regulation written by Austin Sarat and published by Stanford University Press. This book was released on 2011-08-29 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: Law depends on various modes of classification. How an act or a person is classified may be crucial in determining the rights obtained, the procedures employed, and what understandings get attached to the act or person. Critiques of law often reveal how arbitrary its classificatory acts are, but no one doubts their power and consequence. This crucial new book considers the problem of law's physical control of persons and the ways in which this control illuminates competing visions of the law: as both a tool of regulation and an instrument of coercion or punishment. It examines various instances of punishment and regulation to illustrate points of overlap and difference between them, and captures the lived experience of the state's enterprise of subjecting human conduct to the governance of rules. Ultimately, the essays call into question the adequacy of a view of punishment and/or regulation that neglects the perspectives of those who are at the receiving end of these exercises of state power.
Download or read book Regulatory Breakdown written by Cary Coglianese and published by University of Pennsylvania Press. This book was released on 2012-08-16 with total page 290 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Regulation written by Jerry Brito and published by Mercatus Center at George Mason University. This book was released on 2012-08-13 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book United States Code written by United States and published by . This book was released on 2013 with total page 1506 pages. Available in PDF, EPUB and Kindle. Book excerpt: "The United States Code is the official codification of the general and permanent laws of the United States of America. The Code was first published in 1926, and a new edition of the code has been published every six years since 1934. The 2012 edition of the Code incorporates laws enacted through the One Hundred Twelfth Congress, Second Session, the last of which was signed by the President on January 15, 2013. It does not include laws of the One Hundred Thirteenth Congress, First Session, enacted between January 2, 2013, the date it convened, and January 15, 2013. By statutory authority this edition may be cited "U.S.C. 2012 ed." As adopted in 1926, the Code established prima facie the general and permanent laws of the United States. The underlying statutes reprinted in the Code remained in effect and controlled over the Code in case of any discrepancy. In 1947, Congress began enacting individual titles of the Code into positive law. When a title is enacted into positive law, the underlying statutes are repealed and the title then becomes legal evidence of the law. Currently, 26 of the 51 titles in the Code have been so enacted. These are identified in the table of titles near the beginning of each volume. The Law Revision Counsel of the House of Representatives continues to prepare legislation pursuant to 2 U.S.C. 285b to enact the remainder of the Code, on a title-by-title basis, into positive law. The 2012 edition of the Code was prepared and published under the supervision of Ralph V. Seep, Law Revision Counsel. Grateful acknowledgment is made of the contributions by all who helped in this work, particularly the staffs of the Office of the Law Revision Counsel and the Government Printing Office"--Preface.
Download or read book Food Law and Regulation for Non Lawyers written by Marc C. Sanchez and published by Springer. This book was released on 2018-02-22 with total page 287 pages. Available in PDF, EPUB and Kindle. Book excerpt: Designed and modeled after a six-week introductory food law course taught at Northeastern University, Food Law and Regulation for Non-Lawyers offers a succinct overview of key topics and core concepts for food scientists, quality managers, and others who need to understand the regulation of food in the U.S. This second edition includes critical updates on the Food Safety Modernization Act-- the first change to the food safety laws in over 70 years. The seven foundational rules, finalized in 2015, are discussed in detail. The new edition also includes other regulatory updates such as the new Nutrition Fact Panel, changes to the definition of fiber, and the FDA’s attempt to regulate the widely used “healthy” claim. These timely updates, along with the core concepts of the first edition, make the volume an essential and practical tool for regulatory professionals.
Download or read book Law and Economics of Regulation written by Klaus Mathis and published by Springer Nature. This book was released on 2021-04-24 with total page 327 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores current issues regarding the regulation of various economic sectors, theoretically and empirically, discussing both neoclassical and behavioural economics approaches to regulation. Regulation has become one of the main determinants of modern economies, and virtually every sector is subject to general laws and regulations as well as specific rules and standards. A traditional argument to justify regulatory interventions is the promotion of public interests. Fixing markets that lack competition, balancing information asymmetries, internalising externalities, mitigating systemic risks, and protecting consumers from irrational behaviour are frequently invoked to complement the invisible hand of the market with the visible hand of the state.However, regulations can lead to unintended consequences, and serve the interests of powerful private interest groups rather than the public interest and social welfare. In addition, new insights from behavioural economics question the traditional regulatory approaches, most prominently in attitudes towards consumers. Furthermore, digitalisation and technological innovation in general present new challenges in terms of both the type of regulation and the regulatory process.Part I of this book discusses various theoretical approaches to the economic analysis of regulations, while Part II looks at specific applications of the law and economics of regulation.
Download or read book The Oxford Handbook of Law Regulation and Technology written by Roger Brownsword and published by Oxford University Press. This book was released on 2017-07-24 with total page 1342 pages. Available in PDF, EPUB and Kindle. Book excerpt: The variety, pace, and power of technological innovations that have emerged in the 21st Century have been breathtaking. These technological developments, which include advances in networked information and communications, biotechnology, neurotechnology, nanotechnology, robotics, and environmental engineering technology, have raised a number of vital and complex questions. Although these technologies have the potential to generate positive transformation and help address 'grand societal challenges', the novelty associated with technological innovation has also been accompanied by anxieties about their risks and destabilizing effects. Is there a potential harm to human health or the environment? What are the ethical implications? Do this innovations erode of antagonize values such as human dignity, privacy, democracy, or other norms underpinning existing bodies of law and regulation? These technological developments have therefore spawned a nascent but growing body of 'law and technology' scholarship, broadly concerned with exploring the legal, social and ethical dimensions of technological innovation. This handbook collates the many and varied strands of this scholarship, focusing broadly across a range of new and emerging technology and a vast array of social and policy sectors, through which leading scholars in the field interrogate the interfaces between law, emerging technology, and regulation. Structured in five parts, the handbook (I) establishes the collection of essays within existing scholarship concerned with law and technology as well as regulatory governance; (II) explores the relationship between technology development by focusing on core concepts and values which technological developments implicate; (III) studies the challenges for law in responding to the emergence of new technologies, examining how legal norms, doctrine and institutions have been shaped, challenged and destabilized by technology, and even how technologies have been shaped by legal regimes; (IV) provides a critical exploration of the implications of technological innovation, examining the ways in which technological innovation has generated challenges for regulators in the governance of technological development, and the implications of employing new technologies as an instrument of regulatory governance; (V) explores various interfaces between law, regulatory governance, and new technologies across a range of key social domains.
Download or read book Regulation Versus Litigation written by Daniel P. Kessler and published by University of Chicago Press. This book was released on 2011-02 with total page 344 pages. Available in PDF, EPUB and Kindle. Book excerpt: The efficacy of various political institutions is the subject of intense debate between proponents of broad legislative standards enforced through litigation and those who prefer regulation by administrative agencies. This book explores the trade-offs between litigation and regulation, the circumstances in which one approach may outperform the other, and the principles that affect the choice between addressing particular economic activities with one system or the other. Combining theoretical analysis with empirical investigation in a range of industries, including public health, financial markets, medical care, and workplace safety, Regulation versus Litigation sheds light on the costs and benefits of two important instruments of economic policy.
Download or read book Comparative Environmental Law and Regulation written by Nicholas A. Robinson and published by . This book was released on 1996 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Financial Regulation written by MICHAEL. JACKSON BARR (HOWELL. TAHYAR, MARGARET.) and published by Foundation Press. This book was released on 2018-08-06 with total page 1412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Financial Regulation: Law and Policy (2d Edition) introduces the field of financial regulation in a new and accessible way. Even though a decade has passed since the most systemic financial crisis in the last 70 years and eight years have elapsed since a major shift in regulatory design, the world is still grappling with the aftermath. In addition, technology innovations, including Bitcoin and other cryptocurrencies, market forces and a changing political environment all have combined to reframe and reorient public debate over financial regulation. The book has kept up to date with all of these changes. The book analyzes and compares the market and regulatory architecture of the entire U.S. financial sector as it exists today, from banks, insurance companies, and broker-dealers, to asset managers, complex financial conglomerates, and government-sponsored enterprises. The book explores a range of financial activities, from consumer finance and investment to payment systems, securitization, short-term wholesale funding, money markets, and derivatives. The book examines a range of regulatory techniques, including supervision, enforcement, and rule-writing, as well as crisis-fighting tools such as resolution and the lender of last resort. Throughout the book, the authors note the cross-border implications of U.S. rules, and compare, where appropriate, the U.S. financial regulatory framework and policy choices to those in other places around the globe, especially the European Union.
Download or read book Derivatives Law and Regulation written by Gary E. Kalbaugh and published by . This book was released on 2018-05-27 with total page 698 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Law 3 0 written by Roger Brownsword and published by Routledge. This book was released on 2020-05-27 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt: Putting technology front and centre in our thinking about law, this book introduces Law 3.0: the future of the legal landscape. Technology not only disrupts the traditional idea of what it is ‘to think like a lawyer,’ as per Law 1.0; it presents major challenges to regulators who are reasoning in a Law 2.0 mode. As this book demonstrates, the latest developments in technology offer regulators the possibility of employing a technical fix rather than just relying on rules – thus, we are introducing Law 3.0. Law 3.0 represents, so to speak, the state we are in and the conversation that we now need to have, and this book identifies some of the key points for discussion in that conversation. Thinking like a lawyer might continue to be associated with Law 1.0, but from 2020 onward, Law 3.0 is the conversation that we all need to join. And, as this book argues, law and the evolution of legal reasoning cannot be adequately understood unless we grasp the significance of technology in shaping both legal doctrine and our regulatory thinking. This is a book for those studying, or about to study, law – as well as others with interests in the legal, political, and social impact of technology.
Download or read book The Law and Regulation of Financial Institutions written by Milton R. Schroeder and published by . This book was released on 2024-05 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt:
