Food and Drug Law

Author: Peter Barton Hutt
Publisher: Foundation Press
ISBN: 9781609301750
Format: PDF, Mobi
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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 and Regulation

Author: David G. Adams
Publisher:
ISBN: 9781935065739
Format: PDF, ePub, Docs
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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.

Managed Care Pharmacy Practice

Author: Robert P. Navarro
Publisher: Jones & Bartlett Publishers
ISBN: 076378883X
Format: PDF, Mobi
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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.

New Drug Development

Author: Mark P. Mathieu
Publisher: Barnett Educational Services / Chi
ISBN: 9781882615858
Format: PDF, Mobi
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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 Law and Regulation for Non Lawyers

Author: Marc Sanchez
Publisher: Springer
ISBN: 3319124722
Format: PDF, Docs
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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.

Administrative Law

Author: Bernard Schwartz
Publisher: Aspen Publishers
ISBN:
Format: PDF, ePub, Mobi
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Through four editions, the late Bernard Schwartz's clear and accessible casebook has illuminated a path through the intricacies of Administrative Law for both students and instructors. Now, under the direction of Roberto L. Corrada (2000 winner of the prestigious Carnegie fellowship for teaching), Administrative Law: A Casebook returns in a revised, refined, and updated new edition. As in previous editions, this exemplary casebook emphasizes the basic principles of administrative law in an accessible fashion: concise and practical, it covers key topics in just seven chapters clear and straightforward, it was written with students in mind arranged chronologically, it mirrors the course of procedure in actual practice organized for flexibility, it begins with an overview of administrative law and its agencies addressing state law issues, in addition to standard federal topics, it gives students valuable exposure to the arena where most administrative law issues come up In the new edition, changes, revisions, and improvements for an up-to-date portrait of administrative law, including new coverage of the Office of Independent Counsel and Morrison v. Olson FDA v. Brown & Williamson, the decision holding that the FDA does not have the right to regulate the tobacco industry agency regulation of cyberspace and the Electronic Freedom of Information Act new coverage of the doctrine of non-delegation and EPA v. ATA Plus, revised and expanded coverage of standing issues, welfare reform, and the Chevron doctrine and its increasing importance today

Financial Regulation

Author: MICHAEL. JACKSON BARR (HOWELL. TAHYAR, MARGARET.)
Publisher: Foundation Press
ISBN: 9781640202498
Format: PDF, ePub
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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.

Food Law and Policy

Author: Jacob E. Gersen
Publisher: Aspen Casebook
ISBN: 9781454858058
Format: PDF, Kindle
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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.