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Author : JEFFREY. GRAHAM
Publisher : Unknown
Page : 128 pages
File Size : 55,9 Mb
Release : 2019
Category : Electronic
ISBN : 0433501057
Author : National Research Council,Institute of Medicine,Food and Nutrition Board,Board on Agriculture,Committee on Drug Use in Food Animals,Panel on Animal Health, Food Safety, and Public Health
Publisher : National Academies Press
Page : 276 pages
File Size : 49,8 Mb
Release : 1999-01-12
Category : Medical
ISBN : 9780309175777
The use of drugs in food animal production has resulted in benefits throughout the food industry; however, their use has also raised public health safety concerns. The Use of Drugs in Food Animals provides an overview of why and how drugs are used in the major food-producing animal industriesâ€"poultry, dairy, beef, swine, and aquaculture. The volume discusses the prevalence of human pathogens in foods of animal origin. It also addresses the transfer of resistance in animal microbes to human pathogens and the resulting risk of human disease. The committee offers analysis and insight into these areas: Monitoring of drug residues. The book provides a brief overview of how the FDA and USDA monitor drug residues in foods of animal origin and describes quality assurance programs initiated by the poultry, dairy, beef, and swine industries. Antibiotic resistance. The committee reports what is known about this controversial problem and its potential effect on human health. The volume also looks at how drug use may be minimized with new approaches in genetics, nutrition, and animal management.
Author : ADAM I. MUCHMORE
Publisher : Unknown
Page : 734 pages
File Size : 40,5 Mb
Release : 2021-03-14
Category : Electronic
ISBN : 1531004458
Author : Stephen M. Kanovsky,Wayne L. Pines
Publisher : Unknown
Page : 672 pages
File Size : 52,5 Mb
Release : 2020-09
Category : Drugs
ISBN : 1935065874
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 : Upton Sinclair
Publisher : Xist Publishing
Page : 452 pages
File Size : 52,5 Mb
Release : 2016-04-20
Category : Fiction
ISBN : 9781681959757
The Jungle by Upton Sinclair from Coterie Classics All Coterie Classics have been formatted for ereaders and devices and include a bonus link to the free audio book. “The great corporation which employed you lied to you, and lied to the whole country—from top to bottom it was nothing but one gigantic lie.” ― Upton Sinclair, The Jungle Upton’s Sinclair’s classic novel changed the American relationship with food and used its illumination of the horrors of the meat packing industry to indict the evil of American society.
Author : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Sciences Policy,Committee on Pain Management and Regulatory Strategies to Address Prescription Opioid Abuse
Publisher : National Academies Press
Page : 483 pages
File Size : 48,8 Mb
Release : 2017-09-28
Category : Medical
ISBN : 9780309459570
Drug overdose, driven largely by overdose related to the use of opioids, is now the leading cause of unintentional injury death in the United States. The ongoing opioid crisis lies at the intersection of two public health challenges: reducing the burden of suffering from pain and containing the rising toll of the harms that can arise from the use of opioid medications. Chronic pain and opioid use disorder both represent complex human conditions affecting millions of Americans and causing untold disability and loss of function. In the context of the growing opioid problem, the U.S. Food and Drug Administration (FDA) launched an Opioids Action Plan in early 2016. As part of this plan, the FDA asked the National Academies of Sciences, Engineering, and Medicine to convene a committee to update the state of the science on pain research, care, and education and to identify actions the FDA and others can take to respond to the opioid epidemic, with a particular focus on informing FDA's development of a formal method for incorporating individual and societal considerations into its risk-benefit framework for opioid approval and monitoring.
Author : Meredith A. Hickmann
Publisher : Nova Publishers
Page : 212 pages
File Size : 43,5 Mb
Release : 2003
Category : Business & Economics
ISBN : 159033387X
The FDA is responsible for ensuring the safety of foods, drugs, medical devices, cosmetics, and a variety of other products. These products account for 25 cents of every dollar US consumers spend. Under the authority of the Federal Food, Drug, and Cosmetic Act, FDA is responsible for ensuring that these products are safe, accurately labelled, and in the case of drugs and medical devices, effective. FDA's tasks include: enforcement, pre-market product evaluation and approval, post-market surveillance and investigations, publishing of regulations, conducting and monitoring of research, public education, and regulating products and processes to prevent hazards to human health. Contents: Preface; Food and Drug Administration: Selected Funding Data; Food and Drug Administration: Selected Funding and Policy Issues; US European Agricultural Trade: Food and Biotechnology Issues; Food and Drug Administration: Selected Funding and Policy Issues; Food and Drug Administration Modernisation Act of 1997 -- The Provisions; Index.
Author : National Research Council,Institute of Medicine,Board on Agriculture and Natural Resources,Food and Nutrition Board,Committee on the Review of the Food and Drug Administration's Role in Ensuring Safe Food
Publisher : National Academies Press
Page : 589 pages
File Size : 47,7 Mb
Release : 2010-11-04
Category : Medical
ISBN : 9780309163583
Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Author : Beverly McCabe-Sellers,Eric H. Frankel,Jonathan J. Wolfe
Publisher : CRC Press
Page : 937 pages
File Size : 49,6 Mb
Release : 2003-04-29
Category : Medical
ISBN : 9781135504571
With contributions from the fields of pharmacy, dietetics, and medicine, Handbook of Food-Drug Interactions serves as an interdisciplinary guide to the prevention and correction of negative food-drug interactions. Rather than simply list potential food-drug interactions, this book provides explanations and gives specific recommendations based on th
Author : Ping-Chung Kuo
Publisher : Unknown
Page : 276 pages
File Size : 50,5 Mb
Release : 2020
Category : Electronic
ISBN : 3039365401
Aspects of food and drug analysis include exploring natural sources as healthy food, characterizing the molecular structures of bioactive principles, identifying novel drugs, assessing their affinity and specificity, and examining their bioactivities in vitro and in vivo. In addition to extensively applied chromatographic methods, nuclear magnetic resonance (NMR) spectroscopy is also used to screen for novel bioactive molecules. Various new sample preparation methods have been reported, especially for analysis in biological sample matrices. All these new analytical methods accelerate research and will make potential targets available in the near future.
Author : Roseann B. Termini
Publisher : Unknown
Page : 0 pages
File Size : 46,5 Mb
Release : 2017
Category : Biologicals
ISBN : 0984356177
This food and drug law comprehensive book is organized for ease of reading in order to comprehend a complex area of federal regulatory law. There is a separate volume for each subject based on regulation under the United States Federal Food, Drug and Cosmetic Act (FDCA) and related laws all contained in this bound book. Food and Drug Law is organized into subject specific titled volumes with a concise introduction to provide a particular focus for the reader. Praise for Food and Drug LawFood and Drug law has many audiences besides lawyers - health care personnel, doctors, nurses, regulatory, and CEO's to name a few and the author writes in "Plain Language" for reader appeal. - Thomas Mc Grath, M.D., J.D. This is an excellent up-to-date resource. It is used in my graduate school courses as well as in industry. Students keep it as a "desk-top-reference." - Thomas E. Colonna PhD/JD, Director Regulatory Science Program The author details the complexities into subject specific areas. She provides critical information using a practical approach so rare today! - Albert Wertheimer, PhD. Prof. Nova Southeastern University
Author : Holly Fernandez Lynch,I. Glenn Cohen
Publisher : Columbia University Press
Page : 499 pages
File Size : 51,7 Mb
Release : 2015-09-08
Category : Business & Economics
ISBN : 9780231540070
In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.
Author : Anonim
Publisher : Unknown
Page : 144 pages
File Size : 45,8 Mb
Release : 1998
Category : Veterinary drugs
ISBN : UOM:39015035689275
Author : Eunjoo Pacifici,Susan Bain
Publisher : Academic Press
Page : 280 pages
File Size : 50,8 Mb
Release : 2018-06-13
Category : Medical
ISBN : 9780128111567
Today’s challenge, especially for many newcomers to the regulated industry, is not necessarily to gather regulatory information, but to know how to interpret and apply it. The ability to discern what is important from what is not, and to interpret regulatory documents correctly, provides a valuable competitive advantage to any newcomer or established professional in this field. An Overview of FDA Regulated Products: From Drugs and Medical Devices to Food and Tobacco provides a valuable summary of the key information to unveil the meaning of critical, and often complex, regulatory concepts. Concise and easy to read with practical explanations, key points, summaries and case studies, this book highlights the regulatory processes involved in bringing an FDA regulated product from research and development to approval and market. Although the primary focus will be on the US system, this book also features global perspectives where appropriate. A valuable resource for students, professors and professionals, An Overview of FDA Regulated Products illustrates the most important elements and concepts so that the reader can focus on the critical issues and make the necessary connections to be successful. Provides an overview of key regulatory requirements using a practical approach that features detailed discussions of hypothetical and real-world case studies in order to highlight the concepts and applications of regulations Covers all FDA regulated products, including drugs, biologics, medical devices, cosmetics, foods, dietary supplements, cosmetics, veterinary products, tobacco and more in one single reference Illustrates complex topics in a clear, succinct and engaging manner by breaking down technical terms and offering straightforward and easy to understand explanations
Author : Alankar Shrivastava
Publisher : Bentham Science Publishers
Page : 197 pages
File Size : 53,8 Mb
Release : 2018-08-02
Category : Science
ISBN : 9781681086750
Adulteration refers to the practice of altering food or pharmaceutical content to reduce production costs. Factors affecting this practice include market forces such as easy availability of food adulterants, bargaining power of consumers and large demand and supply gaps which incentivize such practices. Technological advancements in chemical analysis now help us to identify adulterated food and drugs more easily. Adulteration Analysis of Some Foods and Drugs is a sourcebook describing analytical methodologies for the determination of adulterants in different food items (milk, honey, juice) and drugs (dietary supplements, sildenafil and specific plant extracts). Additional chapters give guidelines for analyzing a food or drug sample. This book is suitable for researchers working in the field of analytical chemistry for the determination of adulterants. The concise and organized presentation of the contents also serves to enhance the level of knowledge of students undertaking food and drug safety / quality control training courses.