Search Results for "food-and-drug-law-university-casebook-series"

Food and Drug Law

Food and Drug Law

Cases and Materials

  • Author: Peter Barton Hutt,Richard A. Merrill,Lewis A. Grossman
  • Publisher: Foundation Press
  • ISBN: 9781609301750
  • Category: Law
  • Page: 1554
  • View: 4825
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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.

Food and Drug Law

Food and Drug Law

Statutory Supplement : Cases and Materials

  • Author: Peter Barton Hutt,Richard A. Merrill,Lewis A. Grossman
  • Publisher: N.A
  • ISBN: 9781599414560
  • Category: Law
  • Page: 644
  • View: 8729
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Hutt and Merrill's Statutory Supplement to Accompany Food and Drug, 2D

Hutt and Merrill's Statutory Supplement to Accompany Food and Drug, 2D

  • Author: Peter Barton Hutt,Richard A. Merrill
  • Publisher: Foundation Press
  • ISBN: 9781566623438
  • Category: Law
  • Page: 348
  • View: 5906
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This softbound book supplements Food and Drug, 2d, by Peter Barton Hutt and Richard A. Merrill. It is a compilation containing the statutes affecting food and drug law.

Managed Care Pharmacy Practice

Managed Care Pharmacy Practice

  • Author: Robert P. Navarro
  • Publisher: Jones & Bartlett Publishers
  • ISBN: 076378883X
  • Category: Medical
  • Page: 633
  • View: 8113
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Managed Care Pharmacy Practice, Second Edition offers information critical to the development and operation of a managed care pharmacy program. The text also covers the changes that have taken place within the delivery of pharmacy services, as well as the evolving role of pharmacists.

Food Law and Policy

Food Law and Policy

  • Author: Jacob E. Gersen,Margot J. Pollans,Michael T. Roberts
  • Publisher: Aspen Publishers
  • ISBN: 1454858052
  • Category: Law
  • Page: 1176
  • View: 8518
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Food Law and Policy surveys the elements of modern food law. It broadens the coverage of traditional food and drug law topics of safety, marketing, and nutrition, and includes law governing environment, international trade, and other legal aspects of the modern food system. The result is the first casebook that provides a comprehensive treatment of food law as a unique discipline. Key Features: Draws together cases with other regulatory materials such as rulemaking documents and agency requests for proposals for grant funding. Focuses on federal law and includes discussion of innovations in food law happening at the municipal, state and federal level. Covers the latest developments in food law.

Food Law and Regulation for Non-Lawyers

Food Law and Regulation for Non-Lawyers

A US Perspective

  • Author: Marc Sanchez
  • Publisher: Springer
  • ISBN: 3319124722
  • Category: Law
  • Page: 241
  • View: 2450
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The book 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 and dietary supplements in the U.S. It was designed and modeled after a six-week introduction to food law course currently taught at Northeastern University, and serves as a practical tool for regulatory professionals. The book includes a chapter on each major topic, with summations of the legislative history and general legal landscape. Each chapter focuses the reader on major and emerging issues encountered by facilities. A comparative law section at the end of every chapter offers readers an ability to view alternative methods of regulation and enforcement. This design is unique and allows students and working professionals alike to understand core concepts and the practical application of the law to their work. Using a modified casebook method approach, the book also serves as a practical tool for regulatory professionals.

New Drug Development

New Drug Development

A Regulatory Overview

  • Author: Mark P. Mathieu,Christopher-Paul Milne
  • Publisher: Barnett Educational Services / Chi
  • ISBN: 9781882615858
  • Category: Medical
  • Page: 362
  • View: 7296
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"Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including: how the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements; how the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes; how CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process; how the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions; and which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process."--Publisher's description.

Food and Drug Law and Regulation

Food and Drug Law and Regulation

  • Author: David G. Adams,Richard M. Cooper,Martin J. Hahn,Jonathan S. Kahan
  • Publisher: N.A
  • ISBN: 9781935065739
  • Category: Law
  • Page: 995
  • View: 5548
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Written by highly experienced food and drug attorneys and edited by four of the most distinguished authorities in the field, Food and Drug Law and Regulation is the most comprehensive guidebook covering an area that accounts for more than 20 percent of all consumer spending in the United States.

Food Law in the United States

Food Law in the United States

  • Author: Michael T. Roberts
  • Publisher: Cambridge University Press
  • ISBN: 1316425428
  • Category: Law
  • Page: 471
  • View: 804
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As the modern food system continues to transform food - its composition, taste, availability, value, and appearance - consumers are increasingly confronted by legal and regulatory issues that affect us all on a daily basis. In Food Law in the United States, Michael T. Roberts addresses these issues in a comprehensive, systematic manner that lays out the national legal framework for the regulation of food and the legal tools that fill gaps in this framework, including litigation, state law, and private standards. Covering a broad expanse of topics including commerce, food safety, marketing, nutrition, and emerging food-systems issues such as local food, sustainability, security, urban agriculture, and equity, this book is an essential reference for lawyers, students, non-law professionals, and consumer advocates who must understand food law to advance their respective interests.

Global Competition Law and Economics

Global Competition Law and Economics

  • Author: Einer Elhauge,Damien Geradin
  • Publisher: Bloomsbury Publishing
  • ISBN: 1847317677
  • Category: Law
  • Page: 1324
  • View: 8024
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This is the second edition of the acclaimed text on global antitrust law. With markets becoming increasingly global, mergers requiring approval in several different jurisdictions, cartels in one nation affecting supply in others, and countries increasingly entering into treaties with each other about the content or enforcement of competition laws, antitrust law is now a truly global phenomenon. Modern antitrust law is also different because it now reflects an increasingly economic approach to analysing antitrust and competition policy. This innovative work is the only truly comparative and economically sophisticated casebook on the market. Addressed to students from all jurisdictions having competition laws, this casebook provides an in-depth analysis of the two major global antitrust regimes in the world, as well as a summary of selected national antitrust laws. As such it will also serve as a useful reference for practitioners, competition officials and policy-makers interested in competition law. In the four years since the first edition, the increased globalization of antitrust law has continued apace. China, the world's third largest economy after the EU and US, has adopted an antitrust law and other nations have modified and modernized their antitrust regimes. The EU has adopted a new EU Treaty, new EU guidelines on abuse of dominance, new EU guidelines on non-horizontal mergers, and new EU regulations and guidelines on vertical agreements. In the US there have been important new Supreme Court cases (the 2009 Linkline and 2010 American Needle decisions) and the appearance of a new economic approach in the revised 2010 U.S. Merger Guidelines. This new edition expands and updates the pioneering approach of the first edition, addressing new developments not only in the US and EU, but also in Australia, Brazil, Canada, Israel, Japan, South Africa, and South Korea, with expanded coverage of China's new antitrust law, and the antitrust laws of Argentina, Chile, Colombia, Egypt, India, Indonesia, New Zealand, Peru, Russia, Saudi Arabia, Singapore, Taiwan, Thailand, Turkey, and Venezuela. Praise for the first edition '...worthy of considerable praise...contains a vast collection of well-chosen material taking in a wide span of both antitrust and merger law issues. It is well written and clear throughout, particularly on the economic concepts, and provides incisive commentary and questions which inspire further study.' Peter Whelan, Cambridge Law Journal 'Enlightened law professors and law schools will best serve their students not by teaching national competition law but by adopting Global Competition Law and Economics...an excellent book for introductory courses in comparative competition law at either a graduate or undergraduate level.' Okeoghene Odudu, Common Market Law Review '...the best four-and-a-half centimetres of shelf-space that I have seen devoted to competition law and policy issues for a very long time†?.' Yvonne van Roy, New Zealand Law Journal 'Free from the ideologically-driven perspective that can affect other antitrust casebooks, this is also the first casebook organized from inception with an eye directly on the global context...this book may be used in a classroom in Europe just as it will be used in the U.S. The result is a highly welcome contribution to the evolution of competition studies.' Judge Douglas Ginsburg '...this book is the only one on the market that is extremely well suited for use in a comparative antitrust law class...an extraordinarily teachable book that contains everything you might want to present...Finally, the comparative antitrust field has a standard textbook to use. And a wonderful standard it is.' Robert H Lande, University of Baltimore Law School

Food Regulation

Food Regulation

Law, Science, Policy, and Practice

  • Author: Neal D. Fortin
  • Publisher: John Wiley & Sons
  • ISBN: 1118964497
  • Category: Technology & Engineering
  • Page: 552
  • View: 1728
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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

Food and Drug Law

Food and Drug Law

2017 Statutory Supplement

  • Author: Peter Hutt,Lewis Grossman
  • Publisher: Foundation Press
  • ISBN: 9781634602891
  • Category:
  • Page: 1061
  • View: 4729
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This compilation includes the completely updated Federal Food, Drug, and Cosmetic Act, plus an expanded selection of additional federal statutes important to food and drug law. This edition is current through October 2017 and incorporates the amendments made by the 21st Century Cures Act and the FDA Reauthorization Act of 2017.

Food and Drug Law Statutory Supplement

Food and Drug Law Statutory Supplement

  • Author: Peter Barton Hutt,Richard A. Merrill
  • Publisher: Foundation Press
  • ISBN: 9781609302108
  • Category: Law
  • Page: 704
  • View: 7844
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This compilation includes the completely updated Federal Food, Drug, and Cosmetic Act, plus selected additional federal statutes important to food and drug law.

Casebook on benefit and harm

Casebook on benefit and harm

  • Author: UNESCO
  • Publisher: UNESCO
  • ISBN: 9231042033
  • Category: Bioethics
  • Page: 140
  • View: 1771
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Insurance Law and Regulation

Insurance Law and Regulation

  • Author: Kenneth Abraham
  • Publisher: Foundation Press
  • ISBN: 9781609304010
  • Category: Law
  • Page: 809
  • View: 9458
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This casebook, which has been used as the principal text in more than one hundred law schools, contains extensive material on insurance contract formation and interpretation; insurance regulation; insurable interest and liability for bad-faith breach; property, health, life, and disability insurance; commercial general liability and directors & officers liability insurance; auto insurance; and reinsurance. The casebook gives equal emphasis to personal and commercial insurance, and reprints within the relevant chapters four standard-form insurance policies. There is new material on the interpretation of ambiguities, insurance regulation, the Affordable Care Act, directors & officers insurance, and excess coverage.

Legal Writing and Analysis

Legal Writing and Analysis

  • Author: Michael Murray,Christy DeSanctis
  • Publisher: Foundation Press
  • ISBN: 9781609302450
  • Category:
  • Page: 384
  • View: 8421
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This law school text teaches the fundamentals of legal writing, analysis, and the American legal method. It fosters critical lawyering skills, such as how to identify a legal rule from a variety of sources, analyze and explain its components, apply the rule to answer a problem, and communicate the results in an effective manner. In the second edition, coverage of authority and rule formation have been streamlined and tightened. The authors have increased the visual appeal and content of callout boxes, charts, and tables; and they have replaced and shortened the length of examples so as to provide two to three times as many samples of practitioner writing in each chapter. With this new edition, the authors endeavor to train future lawyers to be ethical and professional issue-spotters, analysts, counselors, problem-solvers, and communicators working to advance their clients' interests. For more information and additional teaching materials, visit the companion site.

Encyclopedia of Biotechnology in Agriculture and Food (Print)

Encyclopedia of Biotechnology in Agriculture and Food (Print)

  • Author: Dennis R. Heldman,Dallas G. Hoover,Matthew B. Wheeler
  • Publisher: CRC Press
  • ISBN: 1351452479
  • Category: Technology & Engineering
  • Page: 784
  • View: 4310
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The Encyclopedia of Biotechnology in Agriculture and Food provides users with unprecedented access to nearly 200 entries that cover the entire food system, describing the concepts and processes that are used in the production of raw agricultural materials and food product manufacturing. So that users can locate the information they need quickly without having to flip through pages and pages of content, the encyclopedia avoids unnecessary complication by presenting information in short, accessible overviews. Addresses Environmental Issues & Sustainability in the Context of 21st Century Challenges Edited by a respected team of biotechnology experts, this unrivaled resource includes descriptions and interpretations of molecular biology research, including topics on the science associated with the cloning of animals, the genetic modification of plants, and the enhanced quality of foods. It discusses current and future applications of molecular biology, with contributions on disease resistance in animals, drought-resistant plants, and improved health of consumers via nutritionally enhanced foods. Uses Illustrations to Communicate Essential Concepts & Visually Enhance the Text This one-of-a-kind periodical examines regulation associated with biotechnology applications—with specific attention to genetically modified organisms—regulation differences in various countries, and biotechnology’s impact on the evolution of new applications. The encyclopedia also looks at how biotechnology is covered in the media, as well as the biotechnology/environment interface and consumer acceptance of the products of biotechnology. Rounding out its solid coverage, the encyclopedia discusses the benefits and concerns about biotechnology in the context of risk assessment, food security, and genetic diversity. ALSO AVAILABLE ONLINE This Taylor & Francis encyclopedia is also available through online subscription, offering a variety of extra benefits for both researchers, students, and librarians, including: Citation tracking and alerts Active reference linking Saved searches and marked lists HTML and PDF format options For more information, visit Taylor & Francis Online or contact us to inquire about subscription options and print/online combination packages. US: (Tel) 1.888.318.2367 / (E-mail) [email protected] International: (Tel) +44 (0) 20 7017 6062 / (E-mail) [email protected] Dennis R. Heldman speaks about his work on the CRC Press YouTube Channel.

Cases on Reproductive Rights and Justice

Cases on Reproductive Rights and Justice

  • Author: Melissa Murray,Kristin Luker
  • Publisher: Foundation Press
  • ISBN: 9781609304348
  • Category: Law
  • Page: 949
  • View: 5612
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The first casebook on the subject marks the contours of the field and provides a comprehensive understanding of the law and legal discourse relating to state regulation of sex, bodies, families, and reproduction. This compilation of rich historical and contemporary primary and secondary materials, accompanied by rigorous legal analysis, considers the economic, political, legal, and social factors that influence procreation and parenting. It is attentive to questions of race, ethnicity, socio-economic status, sexual orientation, and ability. Given that reproductive rights are implicated by different bodies of law, the casebook and teacher's manual will serve as guides to help balance expertise in one particular area of the law and enable well-rounded engagement with various issues.

Law and the American Health Care System

Law and the American Health Care System

  • Author: Rand E. Rosenblatt,Sylvia A. Law,Sara Rosenbaum
  • Publisher: N.A
  • ISBN: 9781566624817
  • Category: Law
  • Page: 1346
  • View: 4174
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This law school casebook provides a comprehensive collection of material for investigation of law and the American health care system. Chapters are devoted to topics ranging from regulation of health care companies and providers to fundamental constitutional and bioethical questions regarding the relationship among patients, governments, and health professionals.

International Intellectual Property Law

International Intellectual Property Law

Cases and Materials

  • Author: Paul Goldstein,Marketa Trimble
  • Publisher: Foundation Press
  • ISBN: 9781609301033
  • Category: Law
  • Page: 768
  • View: 3884
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This casebook organizes contemporary foreign, as well as U.S., case law and literature to equip law students with the knowledge they need to engage in international intellectual property practice, in both transactional and litigation settings. Carefully selected materials also expose students to the social, economic, and cultural considerations that underpin intellectual property law around the world. Each field of law - copyright, patent, trademark, unfair competition, trade secrets, industrial design - is introduced by a comprehensive author's note placing the field in its international and comparative law context, and extensive notes on the cases and materials fill in relevant details, including currently and historically important topics. A substantially expanded teacher's guide offers step-by-step help to teaching every case and doctrine.