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Richard Merrill, Peter Hutt, and Lewis Grossman
Approximately 25 cents out of every dollar spent by American consumers is for a commodity regulated by the Food and Drug Administration. The agency has jurisdiction over food, drugs, cosmetics, medical devices, biological products, animal food and drugs, and tobacco products, as well as electronic products that emit radiation and products that spread communicable disease. FDA regulation thus touches the production and sale of most products that fill the shelves of our supermarkets and drug stores and virtually every product prescribed or used by the medical profession. The agency’s responsibilities range from the simplest foods and personal care products to the most technologically sophisticated innovations of biotechnology and medical engineering.
Food and Drug Law is the law governing the actions taken by FDA and its sister agencies to oversee the safety of this vast universe of products, to ensure that their labeling (and in some cases advertising) is accurate and informative, and to shepherd safe and effective new products onto the market.
The book contains many court cases, but to reflect the diverse forums in which food and drug law is developed and enforced, the text also contains many other types illustrative materials: Federal Register preambles, warning letters, regulatory guidance documents, Congressional hearing testimony, scholarly articles, newspaper opinion pieces, and many others. In addition, the book offers a generous amount of original content, in which the authors guide the reader through the complexities of the statutory and regulatory scheme. Moreover, like past editions, the Fourth Edition includes numerous illuminating notes, which offer a gold mine of fascinating examples of the law in action.
The Fourth Edition, like previous editions, is extraordinarily valuable for practitioners. But notably, the book has been reorganized and edited so as to make it more useful than ever for students and professors. Much important contextual material has been moved to the front of the book, so students will grasp essential administrative, jurisdictional, federalism, and enforcement issues before mastering the intricacies of the product-specific chapters. The casebook thus provides an introductory window into administrative law for students who have not yet taken the basic Administrative Law course, as well as for first year students taking Food and Drug Law as an elective. The chapter on human drugs has been thoroughly reorganized to improve its comprehensibility. Throughout the book, other changes to organization and presentation have been made with professors and students in mind.
The Fourth Edition is completely updated through the early fall of 2013. It includes a new chapter on tobacco regulation to reflect the responsibilities FDA acquired under the Family Smoking Prevention and Tobacco Control of 2009. It also incorporates all the other statutory amendments since 2007 (for example, the Food and Drug Administration Act, the Food Safety Modernization Act, and the Food and Drug Administration Safety and Innovation Act). Every major development of the past six years is addressed, from the significant First Amendment cases to the preemption of tort suits to the drug compounding crisis to the regulation of bioengineered salmon. -
Christina Motta and Macarena Saez
Translated and updated from the seminal Spanish text on legal decisions affecting gender and sexuality in Latin America, this English edition is the only law text to focus specifically on the rights of lesbians, gays, bisexuals and the transgender population in addition to women’s rights more broadly. The volume provides close analysis of some of the most important decisions made by Latin American national courts, as well as those made by international legal bodies, that affect the rights and interests of these groups. Specially selected for their depth of argument and value as exemplars, the studies of good legal practice chart the path of the region’s normative values of justice as they have evolved away from a partial, and patriarchal, exercise of the law. They show how cases with vastly differing contexts such as, property rights and domestic violence have resulted in a mixed body of Latin American law. Some decisions are protective of women’s and minority rights. Some assess the wider social impacts of case law in which recognition of the discrete legal identities within households challenges established precepts, including religious ones. Other cases have been chosen as cautionary examples of bad decision-making and for the poverty of their legal debate. Updated to include the latest relevant jurisprudence from across the continent, this book is an informed, cohesive and comprehensive guide to understanding women’s and gender-based rights in Latin America.
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The Progeny: Justice William J. Brennan's Fight to Preserve the Legacy of New York Times v. Sullivan
William J. Snape III
Biodiversity and the Law is a timely and provocative volume that combines historical perspective and cutting-edge legal analysis in an authoritative and broad discussion of biodiversity and the law. Leading legal and policy experts consider a variety of options for the worldwide protection of biodiversity and present a succinct but comprehensive overview of the legal mechanisms available. They examine how conservation advocates can better utilize existing law, and consider what new law is needed.Among the topics considered are: scientific and policy foundations of biodiveristy protection domestic efforts to establish an effective endangered species protection regime international biodiversity protection biodiversity as a genuinely public entity the future of biodiversity law Contributors include Mollie Beattie, Don Waller, Jason Patlis, Lindell Marsh, Todd Olson, Peter Jenkins, Suzanne Iudicello, John Pendergrass, Dinah Bear, Walter Kuhlmann, Rodger Schlickeisen, David Downes, and others.
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International Law & the Resolution of Central and East European Transboundary Environmental Disputes
Paul Williams and Michael P. Scharf
This popular casebook exposes students to the most significant current legal issues relating to international organizations in a stimulating format, employing debates, simulations, and role-play exercises. The chapters cover international organizations related to peace and security, human rights, the environment, and the global economy, both within and outside of the UN system. The third edition updates all of the existing chapters, and adds new chapters addressing the role of international organizations in matters of humanitarian intervention, self-determination, and nuclear nonproliferation.
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Susan Bennett
Community development law has assumed pre-eminence among strategies to alleviate entrenched poverty and create sustainable economic and social change within low income communities. Despite the growing prominence of community development within graduate schools and the helping professions, there is no comprehensive textbook to date. This text provides that resource.
Community Economic Development Law: A Text for Engaged Learning provides a flexible set of materials that faculty can customize to meet the goals of the stand-alone community development class, or the pedagogical needs of community development law clinics. The text enables students to approach the substantive material as would problem-solving, community-based practitioners. They do so by entering the community of Ourfuture City, whose Old World immigrants built a vanished industrial prosperity; and of its neighborhood, Milkweed Park, whose new immigrants and long-time residents confront the stresses of physical and financial isolation, racial segregation and economic disinvestment. Students assume the roles of advisors and advocates for the families, teachers, clergy, bankers, entrepreneurs, non-profits, public institutions, and activists of this prototypical struggling municipality.
The book intersperses overviews of substantive areas that are commonly encountered in community development advocacy with exercises and problems presented by the clients from Milkweed Park. Those areas include entity formation, economic development finance, housing, land use and the emerging field of community justice. The exercises use the substantive law to highlight skills that community development lawyers need to address their clients’ problems and projects, as a basis for in-class discussion and/or preparation for client representation.
Community development law has assumed pre-eminence among strategies to alleviate entrenched poverty and create sustainable economic and social change within low income communities. Despite the growing prominence of community development within graduate schools and the helping professions, there is no comprehensive textbook to date. This text provides that resource.
Community Economic Development Law: A Text for Engaged Learning provides a flexible set of materials that faculty can customize to meet the goals of the stand-alone community development class, or the pedagogical needs of community development law clinics. The text enables students to approach the substantive material as would problem-solving, community-based practitioners. They do so by entering the community of Ourfuture City, whose Old World immigrants built a vanished industrial prosperity; and of its neighborhood, Milkweed Park, whose new immigrants and long-time residents confront the stresses of physical and financial isolation, racial segregation and economic disinvestment. Students assume the roles of advisors and advocates for the families, teachers, clergy, bankers, entrepreneurs, non-profits, public institutions, and activists of this prototypical struggling municipality.
The book intersperses overviews of substantive areas that are commonly encountered in community development advocacy with exercises and problems presented by the clients from Milkweed Park. Those areas include entity formation, economic development finance, housing, land use and the emerging field of community justice. The exercises use the substantive law to highlight skills that community development lawyers need to address their clients’ problems and projects, as a basis for in-class discussion and/or preparation for client representation.
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Susan D. Bennett, Brenda Bratton Blom, Louise A. Howells, and Deborah S. Kenn
Community Economic Development Law: A Text for Engaged Learning provides a flexible set of materials that faculty can customize to meet the goals of the stand-alone community development class, or the pedagogical needs of community development law clinics. The text enables students to approach the substantive material as would problem-solving, community-based practitioners. They do so by entering the community of Ourfuture City, whose Old World immigrants built a vanished industrial prosperity; and of its neighborhood, Milkweed Park, whose new immigrants and long-time residents confront the stresses of physical and financial isolation, racial segregation and economic disinvestment. Students assume the roles of advisors and advocates for the families, teachers, clergy, bankers, entrepreneurs, non-profits, public institutions, and activists of this prototypical struggling municipality.
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Karen B. Brown and David V. Snyder
This title presents twenty-nine topics, prepared by leading scholars in more than 20 countries, providing a comparative analysis of cutting-edge legal topics of the 21st century. Considering topics of vital moment to contemporary legal scholars, the title includes pieces on Surrogate Motherhood, The Balance of Copyright in Comparative Perspective, International Law in Domestic Systems, Constitutional Courts as "Positive Legislators," Same-sex Marriage, Climate Change and the Law, The Regulation of Private Equity, Hedge Funds, and State Funds, and Regulation of Corporate Tax Evasion. Each chapter surveys legal developments in the U.S. and Canada, Europe, Asia, Latin and South America, Africa, and the Middle East in a format that permits the reader easy access to similarities and differences in the approaches of the selected national regimes. This comprehensive volume tells the story of parallel trends in the evolution of legal doctrine despite jurisdictional, cultural, and political barriers. While each of the covered countries stands alone as a sovereign, in a technologically advanced world their disparate systems nonetheless have converged to adopt comparable strategies in dealing with complex legal issues. The volume is a critical addition to the library of any scholar hoping to keep abreast of the major trends in contemporary law.
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Andrew Ferguson
It’s easy to forget how important the jury really is to America. The right to be a juror is one of the fundamental rights guaranteed to all eligible citizens. The right to trial by jury helped spark the American Revolution, was quickly adopted at the Constitutional Convention, and is the only right that appears in both the Constitution and the Bill of Rights. But for most of us, a jury summons is an unwelcome inconvenience. Who has time for jury duty? We have things to do.
In Why Jury Duty Matters, Andrew Guthrie Ferguson reminds us that whether we like it or not, we are all constitutional actors. Jury duty provides an opportunity to reflect on that constitutional responsibility. Combining American history, constitutional law, and personal experience, the book engages citizens in the deeper meaning of jury service. Interweaving constitutional principles into the actual jury experience, this book is a handbook for those Americans who want to enrich the jury experience. It seeks to reconnect ordinary citizens to the constitutional character of a nation by focusing on the important, and largely ignored, democratic lessons of the jury.
Jury duty is a shared American tradition. It connects people across class and race, creates habits of focus and purpose, and teaches values of participation, equality, and deliberation. We know that juries are important for courts, but we don’t know that jury service is important for democracy. This book inspires us to re-examine the jury experience and act on the constitutional principles that guide our country before, during, and after jury service.
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Peter J. Henning, Andrew Taslitz, Margaret L. Paris, Cynthia E. Jones, and Ellen S. Podogor
Mastering Criminal Procedure, Volume 2: The Adjudicatory Stage focuses on the process of a criminal case from the filing of charges against a defendant through the pre-trial and trial stages of the prosecution, and then post-conviction proceedings. This concise guide treats the leading Supreme Court decisions along with a range of statutes and rules that govern the process by which a criminal charge is adjudicated. A number of constitutional protections apply in a prosecution, including the right to a jury trial, confrontation of witnesses, the prohibition on excessive bail, and protection from double jeopardy. A number of procedural rules come into play, including discovery rights, jurisdiction and venue, and post-conviction proceedings, including habeas corpus.
This broad range of topics is explained clearly and succinctly to allow students to master the key concepts and rules related to the adjudication of a criminal prosecution. The authors have experience as prosecutors and defense counsel and have written extensively in the fields of criminal law, criminal procedure, and evidence. -
Sarah Krakoff and Ezra Rosser
Legal and environmental concerns related to Indian law and tribal lands remain an understudied branch of both indigenous law and environmental law. Native American tribes have a far more complex relationship with the environment than is captured by the stereotype of Indians as environmental stewards. Meaningful tribal sovereignty requires that non-Indians recognize the right of Indians to determine their own relationship to the land and the environment. But tribes do not exist in a vacuum: in fact they are deeply affected by off-reservation activities and, similarly, tribal choices often have effects on nearby communities. This book brings together diverse essays by leading Indian law scholars across the disciplines of indigenous and environmental law. The chapters reveal the difficulties encountered by Native American tribes in attempts to establish their own environmental standards within federal Indian law and environmental law structures. Gleaning new insights from a focus on tribal land and property law, the collection studies the practice of tribal sovereignty as experienced by Indians and non-Indians, with an emphasis on the development and regulatory challenges these tribes face in the wake of climate change. This volume will advance the reader's knowledge and understanding of these challenging issues.
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Binny Miller, David Ray Papke, Christine A. Corcos, Melissa Cole Essig, Peter H. Huang, Lenora P. Ledwon, Diane H. Mazur, Carrie Menkel-Meadow, and Philip N. Meyer
The United States is the world's most legalistic nation not only because of its laws, lawyers, and courts but also due to the amount, variety, and appeal of its law-related popular culture. This large body of materials and experiences profoundly affects what Americans expect from their legal institutions and government. Indeed, might it be true that pop cultural law is more important in shaping the lay public's assumptions and expectations than are actual laws and real-life courtroom proceedings? Law and Popular Culture is the first classroom text to examine the full range of American law-related popular culture. Designed primarily for law school use, the text examines the most influential pop cultural media film, radio, television, and inexpensive fiction but each of the text's 14 chapters begins with a list of five readily available Hollywood films that are relevant to that particular chapter. Instructors might screen selections from these lists in conjunction with their courses. After an introduction to the study of popular culture and an outline of the text's goals, the chapters themselves fall into two categories. Half concern the pop cultural portrayals of legal institutions and actors law schools, the legal profession, clients, witnesses, judges, and juries. The second half concern assorted areas of law Constitutional Law, Criminal Law, and Torts from the first-year curriculum and Business Law, Family Law, International Law, and Military Law from standard upper-level electives. Instructors might use the text at the pace of one chapter per week for an entire semester or pick and expand upon selected chapters as they think best.
Overall, Law and Popular Culture underscores and scrutinizes the immense role popular culture plays in shaping the American legal consciousness. Teachers and students alike can use the text to explore what Americans expect from their law and legal institutions while at the same time honing their understanding of law and of the meaning of justice under law.
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Alan S. Nemeth
"v." represents "versus" which is found in legal case names, such as Marbury v. Madison and Roe v. Wade. The book "v." uses legal cases and documents to provide guidance as readers examine issues of law and their impact on society. The reverse is also explored, so that readers become aware of how society in turn influences the law. Rather than discussing law and legal concepts as they are interpreted by the author, the book excerpts both old and new case law, court transcripts, and other material to highlight legal issues that are pertinent today.
As law and society change over time, so too do the fields of law in which an attorney can practice. The unique opening chapter of this book examines animal law, a relatively new and rapidly growing legal field. The issues contained in this first chapter provide an entry point to the broader focus of the book: the law, an ever-changing society, and the relationship between the two. Vote totals for each Supreme Court case presented are also included, which encourage discussion on a particular issue's importance to society or the polarization of society on that issue. -
N. Jeremi Duru
Following the NFL's desegregation in 1946, opportunities became increasingly plentiful for African American players--but not African American coaches. Although Major League Baseball and the NBA made progress in this regard over the years, the NFL's head coaches were almost exclusively white up until the mid-1990s. Advancing the Ball chronicles the campaign of former Cleveland Browns offensive lineman John Wooten to right this wrong and undo decades of discriminatory head coach hiring practices--an initiative that finally bore fruit when he joined forces with attorneys Cyrus Mehri and Johnnie Cochran. Together with a few allies, the triumvirate galvanized the NFL's African American assistant coaches to stand together for equal opportunity and convinced the league to enact the "Rooney Rule," which stipulates that every team must interview at least one minority candidate when searching for a new head coach. In doing so, they spurred a movement that would substantially impact the NFL and, potentially, the nation. Featuring an impassioned foreword by Coach Tony Dungy, Advancing the Ball offers an eye-opening, first-hand look at how a few committed individuals initiated a sea change in America's most popular sport and added an extraordinary new chapter to the civil rights story.
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Roger Fairfax
Grand Jury 2.0: Modern Perspectives on the Grand Jury challenges the American legal culture to re-imagine the grand jury and proposes ways to adapt the grand jury's proud heritage to the needs and realities of modern criminal justice. Chapters provide a rare peek into the black box of grand juror deliberations, reflect on empirical evidence related to the grand jury's often overlooked role in charging and plea bargaining practices, and explore what state grand juries tell us about the institution's potential. Other chapters re-examine the grand jury's seemingly settled historical narrative, emphasize the role the grand jury can perform in empowering and giving voice to citizens and local communities, consider whether the grand jury has a discretionary role to play in the initiation of criminal proceedings, highlight the ways in which grand juries have been employed in the War on Terror, and suggest how the grand jury can add value beyond performing its traditional roles – both inside and outside the criminal justice system.
Fairfax brings together essays written by leading legal scholars and jurists to re-examine the role of the American grand jury, one of the oldest protections known to the American constitutional order. The book's synthesis of criminal law and procedure theory and analysis along with concrete policy proposals makes it required reading for any scholar, student, jurist or lawyer interested in the past, present, or future of the American grand jury.
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Rebecca Hamilton
Fighting for Darfur is the story of what happened when regular citizens took up this twenty-first-century challenge, adopting as their own concern the human rights of people in a remote region of the world that most Americans will never see, and demanding that their elected representatives do the same. Year after year, they held rallies, lobbied Congress, harangued newspaper editors, wrote letters to world leaders, and undertook an array of creative online activities to bring Darfur to the attention of those in power.
At the beginning of the citizen movement for Darfur the key, and somewhat uncomfortable, question was whether the American public, so derided overseas for its parochialism, cared enough about a crisis in Africa to put in the work required to move the behemoth U.S. political system to action. Six years later, this question can be answered resoundingly in the affirmative. While many millions of Americans still do not know about the atrocities that have taken place in Darfur, many millions do — and a meaningful segment among them have taken that knowledge, expanded on it, and turned themselves into tireless and increasingly sophisticated lobbyists for the cause. As one U.S. government official told me, citizen advocates turned Darfur into a domestic issue, an achievement that cannot be overstated.
But now there are new, even less comfortable, questions to be asked. What effect has this remarkable citizens’ movement had on the policy options pursued, and what effect have these policies had on Darfuris and their nation?
As the Darfur movement gained increasing media attention, many a commentator fell into the trap of attributing any policy decision — good, bad, or otherwise — to advocates. But advocacy, even at its most influential, is just one of the many drivers of a system as complex as foreign policy formulation. In starting this research, it was readily apparent that to try and understand what, if any, impact advocacy had on policy, I would need to look at the policy process as a whole and learn about all the other factors influencing policy at any given time, rather than just looking at what advocates were doing. To date, Darfur advocacy has been both blamed and credited for things that were not the consequence of its actions alone or, in some cases, of its actions at all. Part of the motivation for writing this book was to balance the excesses on both sides of this policy influence matter.
The Darfur movement is just one case of a citizen movement and only time will tell whether its lessons can be generalized. Moreover, the most interesting questions usually butt up against a counterfactual that cannot be known — namely, what would have transpired in the absence of the Darfur movement. Nevertheless, the questions I attempt to answer are: Given what we know about the history of U.S. government responses to genocide and mass atrocity, is there reason to believe that the citizen movement led the U.S. government to do anything beyond what we would have expected in the movement’s absence? If not, why not? If so, did these U.S. government actions lead to improvements on the ground in Darfur? And if they did not, then why not and what could have?
Addressing these questions led me into a second layer of issues that were not in the minds of those of us who, at the start of this new century, pinned our hopes for an end to genocide and mass atrocity on the outcry of an engaged American public: What are the options for stopping genocide when — as in Darfur — the U.S government alone does not have enough influence over the state committing the crimes to stop them? What is the future of a U.S.-based citizen movement against genocide and mass atrocity in such a scenario?
The basic structure of the book is chronological. The story takes us from the Darfur massacres of 2003 (when mainstream media and global attention was focused solely on the peace negotiations underway between the north and south of Sudan), to the subsequent shift in focus on Darfur, and finally to the aftermath of the Sudanese national elections in 2010. Individual chapters tackle the policy decisions that commentators have attributed to the Darfur advocacy movement. The final chapter stands alone as a summary what government action was and was not attributable to advocacy, what impact those actions had on the situation in Darfur, and what the Darfur story suggests might be needed to move toward a world without genocide and mass atrocity.
The four parts of this book roughly track the life of the advocacy movement from nonexistence in 2003, to emergence in the shadow of lessons from the 1994 genocide in Rwanda, and then rapidly to substantial influence in the U.S. political realm. But by late 2006 the advocacy movement began to flounder as advocates realized that the United States alone could not “save Darfur” and began to seek other channels through which to pressure Khartoum. Then finally, advocates shifted from focusing on Darfur in isolation to looking at problems between the north and south of Sudan as well.
Today in Darfur, 2.7 million people remain stranded in displaced camps. After rigged Sudanese elections in April 2010 in which most of Darfur’s displaced persons were unwilling or unable to vote, those most responsible for the destruction of their communities have an even greater grip on power than they did at the height of the massacres in 2003 and 2004. To that extent, Fighting for Darfur falls into the bleak body of work that documents the repetitive occurrence of genocide and mass atrocity and the equally repetitive failure to stop it. This time, the story came with a twist, as thousands of regular citizens did their utmost to change this depressing trajectory. But in no way can Darfur be seen as a “success story.” So is this the point at which we all throw up our hands and dismiss as idealistic any hope that mass murder will not continue into the future as it has throughout the centuries? Actually, Fighting for Darfur offers a sliver of a silver lining.
Until Darfur, the persistent failure of the U.S. government to protect civilians from genocidal violence could be all-too-easily attributed to and justified by the absence of a politically relevant outcry from citizens. The insufficiency of that alibi has now been revealed. By telling the story of what happened when citizens did create an outcry, Fighting for Darfur enables us to take the next step and begin to understand the other missing pieces of the genocide prevention puzzle.
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David B. Hunter
The Yearbook of International Environmental Law has established itself as a vital source of information and analysis in an increasingly important legal field. The contributors for this volume are drawn from leading figures around the world who, together with the expert team of editors, have created the best source of information on world-wide events in this field. The article section contains high quality essays on topical subjects and the year-in-review section offers a round-up of legal developments in every part of the world. The third section of the Yearbook contains extensive reviews of recently published books in the area.
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Peter Jaszi and Patricia Aufderheide
In the increasingly complex and combative arena of copyright in the digital age, record companies sue college students over peer-to-peer music sharing, YouTube removes home movies because of a song playing in the background, and filmmakers are denied a distribution deal when some permissions “i” proves undottable. Patricia Aufderheide and Peter Jaszi chart a clear path through the confusion by urging a robust embrace of a principle long-embedded in copyright law, but too often poorly understood—fair use. By challenging the widely held notion that current copyright law has become unworkable and obsolete in the era of digital technologies, Reclaiming Fair Use promises to reshape the debate in both scholarly circles and the creative community.
This indispensable guide distills the authors’ years of experience advising documentary filmmakers, English teachers, performing arts scholars, and other creative professionals into no-nonsense advice and practical examples for content producers. Reclaiming Fair Use begins by surveying the landscape of contemporary copyright law—and the dampening effect it can have on creativity—before laying out how the fair-use principle can be employed to avoid copyright violation. Finally, Aufderheide and Jaszi summarize their work with artists and professional groups to develop best practice documents for fair use and discuss fair use in an international context. Appendixes address common myths about fair use and provide a template for creating the reader’s own best practices. Reclaiming Fair Use will be essential reading for anyone concerned with the law, creativity, and the ever-broadening realm of new media.
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Peter Jaszi, Mario Biagioli, and Martha Woodmansee
Rules regulating access to knowledge are no longer the exclusive province of lawyers and policymakers and instead command the attention of anthropologists, economists, literary theorists, political scientists, artists, historians, and cultural critics. This burgeoning interdisciplinary interest in “intellectual property” has also expanded beyond the conventional categories of patent, copyright, and trademark to encompass a diverse array of topics ranging from traditional knowledge to international trade. Though recognition of the central role played by “knowledge economies” has increased, there is a special urgency associated with present-day inquiries into where rights to information come from, how they are justified, and the ways in which they are deployed.
Making and Unmaking Intellectual Property, edited by Mario Biagioli, Peter Jaszi, and Martha Woodmansee, presents a range of diverse—and even conflicting—contemporary perspectives on intellectual property rights and the contested sources of authority associated with them. Examining fundamental concepts and challenging conventional narratives—including those centered around authorship, invention, and the public domain—this book provides a rich introduction to an important intersection of law, culture, and material production.
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Lewis Grossman
Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management.
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David Hunter
The Yearbook of International Environmental Law has established itself as a vital source of information and analysis in an increasingly important legal field. The contributors for this volume are drawn from leading figures around the world who, together with the expert team of editors, have created the best source of information on world-wide events in this field. The article section contains high quality essays on topical subjects and the year-in-review section offers a round-up of legal developments in every part of the world. The third section of the Yearbook contains extensive reviews of recently published books in the area.
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David Hunter and Daniel Bradlow
To whom are international financial organizations accountable? This unusual book asks not only this searching question, but also examines the extent to which accountability is honoured – or evaded – by the International Monetary Fund, the World Bank Group, and the regional development banks (collectively the international financial institutions, or IFIs).
The fundamental recognition in this book is that the issue of what international legal principles are applicable to the operations of the IFIs is an important topic that would benefit from more rigorous study. Twelve deeply committed contributors – whose work spans the academic, policy, and activist spectrum – suggest that a better understanding of these legal issues could help both the organizations and their Member States structure their transactions in ways that are more compatible with their developmental objectives and their international responsibilities.
Five essays set out the general principles of international law that are applicable to the IFIs and consider how these are or should be evolving to produce IFIs that are respectful subjects of international law and accountable to all relevant stakeholders for their compliance with international law. Six more focus on selected aspects of the IFIs’ operations that both raise important and challenging international legal issues and that have substantial impacts on both the different stakeholders in the operations of the IFIs, and on the sustainability and success of the operations. Introductory and concluding essays frame the volume.
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David Hunter and Daniel D. Bradlow
To whom are international financial organizations accountable? This unusual book asks not only this searching question, but also examines the extent to which accountability is honoured – or evaded – by the International Monetary Fund, the World Bank Group, and the regional development banks (collectively the international financial institutions, or IFIs).
The fundamental recognition in this book is that the issue of what international legal principles are applicable to the operations of the IFIs is an important topic that would benefit from more rigorous study. Twelve deeply committed contributors – whose work spans the academic, policy, and activist spectrum – suggest that a better understanding of these legal issues could help both the organizations and their Member States structure their transactions in ways that are more compatible with their developmental objectives and their international responsibilities.
Five essays set out the general principles of international law that are applicable to the IFIs and consider how these are or should be evolving to produce IFIs that are respectful subjects of international law and accountable to all relevant stakeholders for their compliance with international law. Six more focus on selected aspects of the IFIs’ operations that both raise important and challenging international legal issues and that have substantial impacts on both the different stakeholders in the operations of the IFIs, and on the sustainability and success of the operations. Introductory and concluding essays frame the volume.
The many issues raised include the following:
• IFIs’ impact on economic policies in Member States;
• IFI operations as private financial transactions;
• IFIs as key players in the creation of international law;
• IFIs as promoters of the international capitalist system;
• IFIs as bearers of human rights obligations under international human rights law or as participants in the UN system;
• consequences of an IFI’s breach of its own internal policies or directives;
• IFI immunity;
• IFI capacity to sue and to be sued in national courts;
• ability of various claimants to sue IFIs in domestic courts;
• environmental and social rights and interests of third parties affected by IFI financing;
• right of indigenous people to give their free, prior, and informed consent to IFI operations that affect them; and
• IFIs’ treatment of workers’ rights.
Diverse perspectives in terms of experience, political viewpoint, and focus help define the topic with greater clarity and depth.
In its detailed and critical overview, the book demonstrates that the IFIs have important responsibilities under international law and a powerful capacity to influence the development of international law in a number of areas. It is sure to stimulate thought, debate, research, and action on the topic, and encourage more rigorous engagement between the IFIs and international lawyers.
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David Hunter, James Zalzman, and Durwood Zaelke
The most widely adopted text in the field, this comprehensive, multidisciplinary casebook analyzes the major treaty regimes (with an expanded climate chapter), as well as customary law principles. It emphasizes the dynamic nature of the law-making process, including global environmental diplomacy and the expanding role of non-state actors, including scientists, NGOs, and business. It presents the binding norms of international environmental law, and explains how international cooperation facilitates and strengthens global environmental governance through setting national priorities, coordinating bilateral and multilateral science, financing, technology sharing, and capacity building.
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