Food and Drug Law

Author: Peter Barton Hutt
Publisher: Foundation Press
ISBN: 9781609301750
Format: PDF
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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.

Managed Care Pharmacy Practice

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

Author: Jacob E. Gersen
Publisher: Aspen Publishers
ISBN: 1454858052
Format: PDF, ePub, Docs
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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.

New Drug Development

Author: Mark P. Mathieu
Publisher: Barnett Educational Services / Chi
ISBN: 9781882615858
Format: PDF, ePub
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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 in the United States

Author: Michael T. Roberts
Publisher: Cambridge University Press
ISBN: 1316425428
Format: PDF, ePub, Mobi
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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.

Food Law and Regulation for Non Lawyers

Author: Marc C. Sanchez
Publisher: Springer
ISBN: 3319717030
Format: PDF
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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.

Food and Drug Law and Regulation

Author: David G. Adams
Publisher:
ISBN: 9781935065739
Format: PDF, Kindle
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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 Regulation

Author: Neal D. Fortin
Publisher: John Wiley & Sons
ISBN: 1118964497
Format: PDF, ePub
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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