Medical Devices Law and Regulation Answer Book
Author: Suzan Onel
Publisher:
Published: 2022
Total Pages: 0
ISBN-13: 9781402441622
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A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
Author: Stephen M. Kanovsky
Publisher:
Published: 2020-09
Total Pages: 672
ISBN-13: 9781935065876
DOWNLOAD EBOOKFDLI'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.
American Contagions
Author: John Fabian Witt
Publisher: Yale University Press
Published: 2020-08-31
Total Pages: 185
ISBN-13: 0300257775
DOWNLOAD EBOOKA concise history of how American law has shaped—and been shaped by—the experience of contagion“Contrarians and the civic-minded alike will find Witt’s legal survey a fascinating resource”—Kirkus, starred review “Professor Witt’s book is an original and thoughtful contribution to the interdisciplinary study of disease and American law. Although he covers the broad sweep of the American experience of epidemics from yellow fever to COVID-19, he is especially timely in his exploration of the legal background to the current disaster of the American response to the coronavirus. A thought-provoking, readable, and important work.”—Frank Snowden, author of Epidemics and Society From yellow fever to smallpox to polio to AIDS to COVID-19, epidemics have prompted Americans to make choices and answer questions about their basic values and their laws. In five concise chapters, historian John Fabian Witt traces the legal history of epidemics, showing how infectious disease has both shaped, and been shaped by, the law. Arguing that throughout American history legal approaches to public health have been liberal for some communities and authoritarian for others, Witt shows us how history’s answers to the major questions brought up by previous epidemics help shape our answers today: What is the relationship between individual liberty and the common good? What is the role of the federal government, and what is the role of the states? Will long-standing traditions of government and law give way to the social imperatives of an epidemic? Will we let the inequities of our mixed tradition continue?
Covid-19 in Asia
Author: Victor V. Ramraj
Publisher: Oxford University Press, USA
Published: 2021
Total Pages: 489
ISBN-13: 0197553834
DOWNLOAD EBOOKThis is a book for an extraordinary time, about a pandemic for which there is no modern precedent. It is an edited collection of original essays on Asia's legal and policy responses to the Covid-19 pandemic, which, in a matter of months, swept around the globe, infecting millions. It transformed daily life in almost every corner of the planet: lockdowns of cities and entire countries, physical distancing and quarantines, travel restrictions and border controls, movement-tracking technology, mandatory closures of all but essential services, economic devastation and mass unemployment, and government assistance programs on record-breaking scales. Yet a pandemic on this scale, under contemporary conditions of globalization, has left governments and their advisors scrambling to improvise solutions, often themselves unprecedented in modern times, such as the initial lockdown of Wuhan. This collection of essays analyzes law and policy responses across Asia, identifying cross-cutting themes and challenges. It taps the collective knowledge of an interdisciplinary team of sixty-one researchers both in the service of policy development, and with the goal of establishing a scholarly baseline for research after the storm has passed. The collection begins with an epidemiological overview and survey of the law and policy themes. The jurisdiction-specific case studies and cross-cutting thematic essays cover five topics: first wave containment measures; emergency powers; technology, science, and expertise; politics, religion, and governance; and economy, climate, and sustainability. Chapter 20: Cambodia: Public Health, Economic, and Political Dimensions by Ratana Ly, Vandanet Hing, & Kimsan Soy is available for free.
Public Health Law
Author: Lawrence O. Gostin
Publisher: Univ of California Press
Published: 2008-10-02
Total Pages: 800
ISBN-13: 0520934385
DOWNLOAD EBOOKPublic Health Law, first published in 2000, has been widely acclaimed as the definitive statement on public health law at the start of the twenty-first century. Lawrence O. Gostin's definition was based on the notion that government bears a responsibility for advancing the health and well-being of the general population, and the book developed a rich understanding of the government's powers and duties while showing law to be an effective tool in the realization of a healthier and safer population. In this second edition, Gostin analyzes the major health threats of our times, from emerging infectious diseases and bioterrorism to chronic diseases caused by obesity.
COVID-19, Law, and Regulation
Author: Belinda Bennett
Publisher: Oxford University Press
Published: 2023-01-19
Total Pages: 721
ISBN-13: 0192896741
DOWNLOAD EBOOKCOVID-19 is the most severe pandemic the world has experienced in a century. This book analyses major legal and regulatory responses internationally to COVID-19, and the impact the pandemic has had on human rights and freedoms, governance, the obligations of states and individuals, as well the role of the World Health Organization and other international bodies during this time. The authors examine notable legal challenges to public health measures enforced during the pandemic, such as lockdown orders, curfews, and vaccine mandates. Importantly, the book contextualizes the legal analysis by examining the broader social and economic dimensions of risks posed by the pandemic. The book considers how COVID-19 impacted the operation of the criminal justice system, civil litigation concerning negligently caused deaths and business losses arising from contractual breaches, consumer protection litigation, disciplinary regulation of health practitioners, coronial inquests and other investigations of unexpected deaths, and occupational health and safety issues. The book reflects on the role of the law in facilitating the remarkable scientific and epidemiological achievements during the pandemic, but also the challenges of ensuring the swift production and equitable distribution of treatments and vaccines. It concludes by considering the possibilities that the legal and regulatory responses to this pandemic have illuminated for effectively tackling future global health crises.
International Health Regulations (2005)
Author: World Health Organization
Publisher: World Health Organization
Published: 2008-12-15
Total Pages: 82
ISBN-13: 9241580410
DOWNLOAD EBOOKIn response to the call of the 48th World Health Assembly for a substantial revision of the International Health Regulations, this new edition of the Regulations will enter into force on June 15, 2007. The purpose and scope of the Regulations are "to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade." The Regulations also cover certificates applicable to international travel and transport, and requirements for international ports, airports and ground crossings.
Vulnerable
Author: Colleen M. Flood
Publisher: University of Ottawa Press
Published: 2020-07-14
Total Pages: 850
ISBN-13: 077663643X
DOWNLOAD EBOOKThe novel coronavirus SARS-CoV-2, which causes the disease known as COVID-19, has infected people in 212 countries so far and on every continent except Antarctica. Vast changes to our home lives, social interactions, government functioning and relations between countries have swept the world in a few months and are difficult to hold in one’s mind at one time. That is why a collaborative effort such as this edited, multidisciplinary collection is needed. This book confronts the vulnerabilities and interconnectedness made visible by the pandemic and its consequences, along with the legal, ethical and policy responses. These include vulnerabilities for people who have been harmed or will be harmed by the virus directly and those harmed by measures taken to slow its relentless march; vulnerabilities exposed in our institutions, governance and legal structures; and vulnerabilities in other countries and at the global level where persistent injustices harm us all. Hopefully, COVID-19 will forces us to deeply reflect on how we govern and our policy priorities; to focus preparedness, precaution, and recovery to include all, not just some. Published in English with some chapters in French.
Regulatory Theory
Author: Peter Drahos
Publisher: ANU Press
Published: 2017-02-23
Total Pages: 820
ISBN-13: 1760461024
DOWNLOAD EBOOKThis volume introduces readers to regulatory theory. Aimed at practitioners, postgraduate students and those interested in regulation as a cross-cutting theme in the social sciences, Regulatory Theory includes chapters on the social-psychological foundations of regulation as well as theories of regulation such as responsive regulation, smart regulation and nodal governance. It explores the key themes of compliance, legal pluralism, meta-regulation, the rule of law, risk, accountability, globalisation and regulatory capitalism. The environment, crime, health, human rights, investment, migration and tax are among the fields of regulation considered in this ground-breaking book. Each chapter introduces the reader to key concepts and ideas and contains suggestions for further reading. The contributors, who either are or have been connected to the Regulatory Institutions Network (RegNet) at The Australian National University, include John Braithwaite, Valerie Braithwaite, Peter Grabosky, Neil Gunningham, Fiona Haines, Terry Halliday, David Levi-Faur, Christine Parker, Colin Scott and Clifford Shearing.
Pandemic Politics
Author: Shana Kushner Gadarian
Publisher: Princeton University Press
Published: 2024-11-05
Total Pages: 400
ISBN-13: 069121901X
DOWNLOAD EBOOKHow the politicization of the pandemic endangers our lives—and our democracy COVID-19 has killed more people than any war or public health crisis in American history, but the scale and grim human toll of the pandemic were not inevitable. Pandemic Politics examines how Donald Trump politicized COVID-19, shedding new light on how his administration tied the pandemic to the president’s political fate in an election year and chose partisanship over public health, with disastrous consequences for all of us. Health is not an inherently polarizing issue, but the Trump administration’s partisan response to COVID-19 led ordinary citizens to prioritize what was good for their “team” rather than what was good for their country. Democrats, in turn, viewed the crisis as evidence of Trump’s indifference to public well-being. At a time when solidarity and bipartisan unity were sorely needed, Americans came to see the pandemic in partisan terms, adopting behaviors and attitudes that continue to divide us today. This book draws on a wealth of new data on public opinion to show how pandemic politics has touched all aspects of our lives—from the economy to race and immigration—and puts America’s COVID-19 response in global perspective. An in-depth account of a uniquely American tragedy, Pandemic Politics reveals how the politicization of the COVID-19 pandemic has profound and troubling implications for public health and the future of democracy itself.
