Author: Joy J. Liu Publisher: ISBN: 9781935065869 Category : Law Languages : en Pages : 662
Book Description
The FDCA Statutory Supplement, 2018 is the indispensable tool for FDA law practitioners. Cross-referencing of the numerous legislative amendments with the original statute facilitates quick research and citation, and recent changes are highlighted with simple formatting. Access to an electronic version is included with each print copy.
Author: B. Bryan Haycock Publisher: Momentum Press ISBN: 1606507567 Category : Medical Languages : en Pages : 125
Book Description
This book provides an overview of dietary supplements including their definition, how they are manufactured and regulated, what forms they are sold in, and what the most popular products are. An effort is made to provide relevant information on the background, mechanism of action, and the clinical evidence demonstrating their efficacy or lack thereof. This book is important given the popularity of dietary supplements and the controversies around their sale and use. Negative portrayal of the industry by the media, and unscrupulous companies that make false and misleading claims about their products, fuel the controversy. At the same time, epidemiological data demonstrates that the proper use of dietary supplements could save thousands of lives and billions of dollars in health care costs. This book is an attempt to contribute an objective perspective on the matter.
Author: Donald O. Beers Publisher: Wolters Kluwer ISBN: 1454836091 Category : Law Languages : en Pages : 2154
Book Description
Completely updated, the new Eighth Edition of Generic and Innovator Drugs: A Guide to FDA Approval Requirements provides indispensable and practical insights into the FDA approval process. Youand’ll find comprehensive coverage of: Abbreviated new drug applications 505(b)(2) new drug applications Delaying approval of competing products FDA approval of biologic drugs No other book can cover the drug approval process as thoroughly, answering important questions like these: What is required to extend the patent of an FDA-approved product? When must a generic manufacturer notify the innovator manufacturer when submitting an ANDA or 505(b)(2) application? When does the FDA delay approvals because of patent claims, and when does it ignore patents? How can one challenge an FDA exclusivity decision? When can a manufacturer safely sell a drug without prior FDA approval? In what circumstances can a generic manufacturer obtain FDA permission to file an ANDA for a variant of an existing drug? When will the FDA waive or reduce prescription drug user fees? How can a company or an individual avoid debarment? What steps are necessary to comply with the FDAand’s Fraud Policy? When and how can a drug company take advantage of FDA accelerated approval procedures? What are the labeling requirements for exporting approved drugs? How have the changes made by the FDA Safety and Innovation Act, including the Prescription Drug User Fee Act, the Generic Drug User Fee Amendments and the Biosimilars User Fee Act, and the Generating Antibiotic Incentives Now Act affected the overall statutory scheme? Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition provides step-by-step guidance of the approval process and expert interpretation of: The Hatch-Waxman Act (Drug Price Competition and Patent Restoration Act) The Medicare Prescription Drug, Improvement, and Modernization Act The Food and Drug Administration Modernization Act The FDA Export Reform and Enhancement Act The Biologics Price Competition and Innovation Act And more! AUTHOR NOTE Donald O. Beersand’ contributions to this publication were completed before he rejoined the Food and Drug Administration. He has had no part in writing and revising this Eighth Edition.
Author: Jacob E. Gersen Publisher: Aspen Publishing ISBN: 1454898410 Category : Law Languages : en Pages : 903
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: Ramesh C Gupta Publisher: Academic Press ISBN: 0128212462 Category : Medical Languages : en Pages : 1397
Book Description
Nutraceuticals: Efficacy, Safety and Toxicity, Second Edition, brings together everything that is currently known about nutraceuticals and their potential toxic effects. The book introduces readers to nutraceuticals, herbal medicines, Ayurvedic medicines, prebiotics, probiotics, adaptogens, and their uses and specific applications. This essential reference discusses the mechanism of action for the judicious use of these nutraceuticals and the best tools for their evaluation before detailing the safety and toxicity of nutraceuticals and interactions with other therapeutic drugs. Finally, and crucially, regulatory aspects from around the world are covered. Completely revised and updated, this updated edition provides toxicologists, pharmacologists, pharmaceutical scientists, and those interested in medicinal plants and natural products with a comprehensive overview of the most effective tools upon which to evaluate the safety and toxicity of nutraceuticals, prebiotics, probiotics and alternative medicines. - Presents a completely revised and updated resource on the impact of nutraceuticals and various disease states such as diabetes and ophthalmic and dermal diseases - Grants an overview of the current state-of-the-science of nutraceuticals, their use and applications, and known adverse effects - Provides effective tools to evaluate the potential toxicity of any nutraceutical - Includes details of regulatory issues as written by international experts
Author: Bhushan R. Rane Publisher: CRC Press ISBN: 1000869628 Category : Medical Languages : en Pages : 504
Book Description
Here is an in-depth and informative introduction to dietary fibers and food supplements, elaborating on their uses and benefits in the prevention and treatment of such health issues and diseases as diabetes, obesity, coronary heart disease, colorectal and other types of cancer, and gut health. The book also discusses the formulation-based approaches for the delivery of food supplements and dietary fibers as well as the use of botanicals in dietary supplements and fibers. The chapter on regulatory guidance of food supplement and dietary fiber discusses the current statutes and regulations addressing dietary ingredients, manufacturing standards, safety, labelling, and claims. The book explains how dietary fibers and food supplements work to maintain gut health, addressing such issues as constipation, loose stools, inflammatory bowel diseases, hiatal hernias, gastroesophageal reflux disease, Barrett’s esophagus, diverticular disease, hemorrhoids, peptic ulcers, gastritis, celiac disease, gallstones, and colon cancer.
Author: Carolyn Newberry Publisher: Springer Nature ISBN: 3030949532 Category : Medical Languages : en Pages : 305
Book Description
This book serves as a definitive nutritional reference for medical practitioners who care for patients with digestive diseases. This first-of-its-kind title explores the critical link between nutrition and weight and digestive health and organizes the necessary information for easy use for clinicians across specialties. The book is divided into four sections; the first section outlines basic nutritional concepts that lay a foundation for future chapters. This includes discussion of the gastrointestinal tract’s role in digestion and metabolism, an outline of dietary composition and associated deficiencies, and a review of nutritional assessment and general therapeutic principles. Next, the second section outlines dietary and nutritional implications of specific digestive diseases organized by affected gastrointestinal organs. Following this, the third section discusses appetite regulation, weight management, and obesity’s association with gastrointestinal diseases. It also discusses the importance of comprehensive, multi-disciplinary obesity care including a review of dietary, pharmacological, endoscopic, and surgical options that promote weight loss. In concluding the book, the fourth section discusses foundational nutritional support concepts. Nutrition, Weight, and Digestive Health is an invaluable reference for medical practitioners seeking a title that explores important and revolutionary elements to the medical care of those with digestive diseases.
Author: Joy J. Liu
Author: ADAM I. MUCHMORE
Author: B. Bryan Haycock
Author: Jennifer Bragg
Author: United States. Federal Trade Commission. Bureau of Consumer Protection
Author: Donald O. Beers
Author: Jacob E. Gersen
Author: Ramesh C Gupta
Author: Bhushan R. Rane
Author: Carolyn Newberry