A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition PDF Download
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Author: Stephen M. Kanovsky
Publisher:
ISBN: 9781935065876
Category : Drugs
Languages : en
Pages : 672
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Book Description
FDLI'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.
Author: Stephen M. Kanovsky
Publisher:
ISBN: 9781935065876
Category : Drugs
Languages : en
Pages : 672
Get Book Here
Book Description
FDLI'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.
Author: AMERICAN BAR ASSOCIATION.
Publisher:
ISBN: 9781641059510
Category : Law
Languages : en
Pages : 232
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Book Description
"The goal of this practical guide to food law is to offer attorneys of all stripes an introduction to how different areas of law and legal practice intersect with food"--
Author: Neal D. Fortin
Publisher: John Wiley & Sons
ISBN: 1118964497
Category : Technology & Engineering
Languages : en
Pages : 1028
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Book Description
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
Author: Patricia A. Curtis
Publisher: John Wiley & Sons
ISBN: 1118227735
Category : Technology & Engineering
Languages : en
Pages : 346
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Book Description
For both student food scientists and experienced professionals, a knowledge of U.S. food law is the foundation that supports an understanding of all industry regulation. Based on a popular internet course, Guide to Food Laws and Regulations, 2nd Edition informs students on the significance, range, and background of food laws and gives tools for finding current regulations. This compact resource outlines major U.S. food laws, factors that led to their passage, and explains the role of key agencies like the FDA and FSIS in regulation and enforcement. Students are directed to internet sites as well as to indexes and resources available from the Federal government. Other topics include religious dietary law, Occupational Safety and Health Administration regulations, environmental regulations, HACCP and GMPs, laws governing health claims, and the regulation of biotechnology. New to this edition are six chapters on subjects that have risen to prominence during the last few years: Poultry Processing Regulations Federal Trade Commission Animal Welfare Regulations and Food Production Egg Laws and Regulations Catfish Regulations Locating Laws and Regulations Guide to Food Laws and Regulations, 2nd Edition is an ideal sourcebook for students and professionals in food science and technology, chemistry, biosystems engineering, food animal production and medicine, agribusiness, and other closely related fields.
Author: United States. Food Safety and Inspection Service. Standards and Labeling Division
Publisher:
ISBN:
Category : Food
Languages : en
Pages : 366
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Book Description
Author: Jacob E. Gersen
Publisher: Aspen Publishing
ISBN: 1454898410
Category : Law
Languages : en
Pages : 903
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Book Description
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.
Author:
Publisher:
ISBN:
Category : Food
Languages : en
Pages : 72
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Book Description
Author: Barry Leonard
Publisher: DIANE Publishing
ISBN: 143798746X
Category : Technology & Engineering
Languages : en
Pages : 476
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Book Description
This guidance will assist processors of fish and fishery products in the development of their Hazard Analysis Critical Control Point (HACCP) plans. Processors of fish and fishery products will find info. that will help them identify hazards that are associated with their products, and help them formulate control strategies. It will help consumers understand commercial seafood safety in terms of hazards and their controls. It does not specifically address safe handling practices by consumers or by retail estab., although the concepts contained in this guidance are applicable to both. This guidance will serve as a tool to be used by fed. and state regulatory officials in the evaluation of HACCP plans for fish and fishery products. Illustrations. This is a print on demand report.
Author: Committee to Ensure Safe Food from Production to Consumption
Publisher: National Academies Press
ISBN: 0309593409
Category : Medical
Languages : en
Pages : 209
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Book Description
How safe is our food supply? Each year the media report what appears to be growing concern related to illness caused by the food consumed by Americans. These food borne illnesses are caused by pathogenic microorganisms, pesticide residues, and food additives. Recent actions taken at the federal, state, and local levels in response to the increase in reported incidences of food borne illnesses point to the need to evaluate the food safety system in the United States. This book assesses the effectiveness of the current food safety system and provides recommendations on changes needed to ensure an effective science-based food safety system. Ensuring Safe Food discusses such important issues as: What are the primary hazards associated with the food supply? What gaps exist in the current system for ensuring a safe food supply? What effects do trends in food consumption have on food safety? What is the impact of food preparation and handling practices in the home, in food services, or in production operations on the risk of food borne illnesses? What organizational changes in responsibility or oversight could be made to increase the effectiveness of the food safety system in the United States? Current concerns associated with microbiological, chemical, and physical hazards in the food supply are discussed. The book also considers how changes in technology and food processing might introduce new risks. Recommendations are made on steps for developing a coordinated, unified system for food safety. The book also highlights areas that need additional study. Ensuring Safe Food will be important for policymakers, food trade professionals, food producers, food processors, food researchers, public health professionals, and consumers.
Author: Christine Boisrobert
Publisher: Academic Press
ISBN: 0080889301
Category : Technology & Engineering
Languages : en
Pages : 475
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Book Description
Taking into account toxicity levels at normal consumption levels, intake per kg bodyweight and other acknowledged considerations, each chapter in this book will be based on one or more proven examples. It is intended to provide specific examples and potential improvements to the safety of the world's food supply, while also increasing the amount of food available to those in undernourished countries. This book is designed to to provide science-based tools for improving legislation and regulation. - Reduce amount of food destroyed due to difference in regulations between nations - Positively impact the time-to-market of new food products by recognizing benefit of "one rule that applies to all" - Use the comparison of regulations and resulting consequences to make appropriate, fully-informed decisions - Employ proven science to obtain global consensus for regulations - Understand how to harmonize test protocols and analytical methods for accurate measurement and evaluation - Take advantage of using a risk/benefit based approach rather than risk/avoidance to maximize regulatory decisions
