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Author :
Publisher :
ISBN 13 :
Total Pages : 692 pages
Book Rating : 4.:/5 (37 download)
Download or read book Food and Drug Law Journal written by and published by . This book was released on 1914 with total page 692 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Stephen M. Kanovsky
Publisher :
ISBN 13 : 9781935065876
Total Pages : 672 pages
Book Rating : 4.0/5 (658 download)
Download or read book A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 :
Publisher :
ISBN 13 :
Total Pages : 858 pages
Book Rating : 4.F/5 ( download)
Download or read book Food, Drug, Cosmetic Law Journal written by and published by . This book was released on 1990 with total page 858 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Holly Fernandez Lynch
Publisher : Columbia University Press
ISBN 13 : 0231540078
Total Pages : 499 pages
Book Rating : 4.2/5 (315 download)
Download or read book FDA in the Twenty-First Century written by Holly Fernandez Lynch and published by Columbia University Press. This book was released on 2015-09-08 with total page 499 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Peter Barton Hutt
Publisher :
ISBN 13 :
Total Pages : 1462 pages
Book Rating : 4.F/5 ( download)
Download or read book Food and Drug Law written by Peter Barton Hutt and published by . This book was released on 1991 with total page 1462 pages. Available in PDF, EPUB and Kindle. Book excerpt: This casebook provides detailed information on legal aspects food and drug law. The casebook provides the tools for fast, easy, on-point research. Part of the University Casebook Series®, it includes selected cases designed to illustrate the development of a body of law on a particular subject. Text and explanatory materials designed for law study accompany the cases.
Author : Peter Hutt
Publisher : Foundation Press
ISBN 13 : 9781636596952
Total Pages : 0 pages
Book Rating : 4.5/5 (969 download)
Download or read book Food and Drug Law written by Peter Hutt and published by Foundation Press. This book was released on 2022-08-19 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Roughly 20-25 cents out of every dollar spent by American consumers is for a product regulated by the U.S. Food and Drug Administration. The agency has jurisdiction over food, drugs, cosmetics, medical devices, biological products (including vaccines), 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 most products that fill the shelves of our supermarkets and drug stores and virtually every product prescribed or used by the medical profession. Indeed, few other agencies regulate products or activities that play so intimate a role in our daily lives. 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 the labeling (and in some cases advertising) of products is accurate and reliable, and to shepherd safe and effective new medical products onto the market. The book contains not only the most important court cases in the field, but also materials that show how food and drug law is developed and enforced outside of court, including: Federal Register notices, warning letters, guidance documents, Congressional hearings and investigations, scholarly research, media opinions, and many others. Additionally, the authors offer significant original content to guide the reader through the myriad complexities of the field. Likewise, the Fifth Edition includes carefully curated notes that illuminate the law in action. The Fifth Edition, like previous editions, is an invaluable resource for practitioners. But the book has been reorganized and edited from top to bottom to make it more accessible than ever for students and professors. The Fifth Edition completely updates the Fourth Edition of 2014 through February 2022. It addresses all statutory developments since 2014, including, for example, the National Bioengineered Food Disclosure Standard Act of 2016, the 21st Century Cures Act of 2016, the FDA Reauthorization Action of 2017, the Right to Try Act of 2018, the Pediatric Drugs and Devices Act of 2017, and the Coronavirus Aid, Relief, and Economic Security Act of 2020. Every major development of the past eight years is addressed, from the flood of new mobile and digital devices to the vital work of the FDA during the COVID-19 pandemic. The authors combine their knowledge of the rich histories in each product area with a deep understanding of the law and the agency to explain the current state of food and drug law and signal where it might be headed.
Author : Peter Barton Hutt
Publisher :
ISBN 13 : 9781609301750
Total Pages : 0 pages
Book Rating : 4.3/5 (17 download)
Download or read book Food and Drug Law written by Peter Barton Hutt and published by . This book was released on 2014 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Hardbound - New, hardbound print book.
Author : Emily Strunk
Publisher :
ISBN 13 : 9781935065937
Total Pages : pages
Book Rating : 4.0/5 (659 download)
Download or read book FDCA Statutory Supplement, 2021 (2nd Edition) written by Emily Strunk and published by . This book was released on 2021-05-31 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: The FDCA Statutory Supplement, 2021 is an indispensable tool for FDA law practitioners. This publication provides cross-referencing of the numerous legislative amendments with the original statute, facilitating quick research and citation, and highlights recent changes through simple formatting. This edition is updated to incorporate the CARES Act and other statutory amendments since the 2018 edition. The appendix contains relevant portions of related statutes. This publication is available in both print and E-book versions.
Author : Fran Hawthorne
Publisher : John Wiley & Sons
ISBN 13 : 1118040066
Total Pages : 393 pages
Book Rating : 4.1/5 (18 download)
Download or read book Inside the FDA written by Fran Hawthorne and published by John Wiley & Sons. This book was released on 2010-12-13 with total page 393 pages. Available in PDF, EPUB and Kindle. Book excerpt: The forces that shape America's most powerful consumer agency Because of the importance of what it regulates, the FDA comes under tremendous political, industry, and consumer pressure. But the pressure goes far beyond the ordinary lobbying of Washington trade groups. Its mandate-one quarter of the national economy-brings the FDA into the middle of some of the most important and contentious issues of modern society. From "designer" babies and abortion to the price of prescription drugs and the role of government itself, Inside the FDA takes readers on an intriguing journey into the world of today's most powerful consumer agency. In a time when companies continue to accuse the FDA of nitpicking and needlessly delaying needed new drugs, and consumers are convinced that the agency bends to industry pressure by rushing unsafe drugs to market, Inside the FDA digs deep to reveal the truth. Through scores of interviews and real-world stories, Hawthorne also shows how and why the agency makes some of its most controversial decisions as well as how its recent reaction to certain issues-including the revolutionary cancer drug Erbitux, stem cell research, and bioengineering of food-may jeopardize its ability to keep up with future scientific developments. Inside the FDA takes a closer look at the practices, people, and politics of this crucial watchdog in light of the competing pressures and trends of modern society, revealing what the FDA is supposed to do, what it actually does-and fails to do-who it influences, and how it could better fulfill its mandate. The decisions that the FDA makes are literally life and death. Inside the FDA provides a sophisticated account of how this vitally important agency struggles to balance bureaucracy and politics with its overriding mission to promote the country's health.
Author : Mikkael A. Sekeres
Publisher : MIT Press
ISBN 13 : 0262548399
Total Pages : 319 pages
Book Rating : 4.2/5 (625 download)
Download or read book Drugs and the FDA written by Mikkael A. Sekeres and published by MIT Press. This book was released on 2024-02-06 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: How the FDA was shaped by public health crises and patient advocacy, told against a background of the contentious hearings on the breast cancer drug Avastin. Food and Drug Administration approval for COVID-19 vaccines and the controversial Alzheimer’s drug Aduhelm made headlines, but few of us know much about how the agency does its work. Why is the FDA the ultimate US authority on a drug’s safety and efficacy? In Drugs and the FDA, Mikkael Sekeres—a leading oncologist and former chair of the FDA’s cancer drug advisory committee—tells the story of how the FDA became the most trusted regulatory agency in the world. It took a series of tragedies and health crises, as well as patient advocacy, for the government to take responsibility for ensuring the efficacy and safety of drugs and medical devices. Before the FDA existed, drug makers could hawk any potion, claim treatment of any ailment, and make any promise on a label. But then, throughout the twentieth century, the government was forced to take action when children were poisoned by contaminated diphtheria and smallpox vaccines, an early antibiotic contained antifreeze, a drug prescribed for morning sickness in pregnancy caused babies to be born disfigured, and access to AIDS drugs was limited to a few clinical trials while thousands died. Sekeres describes all these events against the backdrop of the contentious 2011 hearings on the breast cancer drug Avastin, in which he participated as a panel member. The Avastin hearings, he says, put to the test a century of the FDA’s evolution, demonstrating how its system of checks and balances works—or doesn’t work.
Author : Tom Brody
Publisher : Academic Press
ISBN 13 : 0128146486
Total Pages : 670 pages
Book Rating : 4.1/5 (281 download)
Download or read book FDA's Drug Review Process and the Package Label written by Tom Brody and published by Academic Press. This book was released on 2017-12-13 with total page 670 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA's Drug Review Process and the Package Label provides guidance to pharmaceutical companies for writing FDA-submissions, such as the NDA, BLA, Clinical Study Reports, and Investigator's Brochures. The book provides guidance to medical writers for drafting FDA-submissions in a way more likely to persuade FDA reviewers to grant approval of the drug. In detail, the book reproduces data on efficacy and safety from one hundred different FDA-submissions (NDAs, BLAs). The book reproduces comments and complaints from FDA reviewers regarding data that are fragmentary, ambiguous, or that detract from the drug's approvability, and the book reveals how sponsors overcame FDA's concerns and how sponsors succeeded in persuading FDA to grant approval of the drug. The book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely text and data from NDAs and BLAs, as published on FDA's website. The source material for writing this book included about 80,000 pages from FDA's Medical Reviews, FDA's Clinical Pharmacology Reviews, and FDA's Pharmacology Reviews, from one hundred different NDAs or BLAs for one hundred different drugs. Each chapter focuses on a different section of the package label, e.g., the Dosage and Administration section or the Drug Interactions section, and demonstrates how the sponsor's data supported that section of the package label. Reveals strategies for winning FDA approval and for drafting the package label Examples are from one hundred FDA-submissions (NDAs, BLAs) for one hundred different drugs, e.g., for oncology, metabolic diseases, autoimmune diseases, and neurological diseases This book uses the most reliable and comprehensive source of information available for writing FDA-submissions, namely, the data from NDAs and BLAs as published on FDA's website at the time FDA grants approval to the drug
Author : Jeffrey Gibbs
Publisher :
ISBN 13 : 9781935065890
Total Pages : pages
Book Rating : 4.0/5 (658 download)
Download or read book Diagnostics at a Crossroads: Navigating IVD Regulation in a Changing Environment written by Jeffrey Gibbs and published by . This book was released on 2020-12-20 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309163587
Total Pages : 589 pages
Book Rating : 4.3/5 (91 download)
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Joy J. Liu
Publisher :
ISBN 13 : 9781935065869
Total Pages : 662 pages
Book Rating : 4.0/5 (658 download)
Download or read book FDCA Statutory Supplement, 2018 written by Joy J. Liu and published by . This book was released on 2018-02-07 with total page 662 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : National Academies of Sciences, Engineering, and Medicine
Publisher : National Academies Press
ISBN 13 : 0309459575
Total Pages : 483 pages
Book Rating : 4.3/5 (94 download)
Download or read book Pain Management and the Opioid Epidemic written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-09-28 with total page 483 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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 : Food and Drug Law Institute (U.S.)
Publisher :
ISBN 13 : 9781935065449
Total Pages : 1032 pages
Book Rating : 4.0/5 (654 download)
Download or read book Food and Drug Law and Regulation written by Food and Drug Law Institute (U.S.) and published by . This book was released on 2011 with total page 1032 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Kenneth R. Piña
Publisher : Food and Drug Law Institute
ISBN 13 : 9781935065845
Total Pages : 618 pages
Book Rating : 4.0/5 (658 download)
Download or read book A Practical Guide to Fda's Food and Drug Law and Regulation, Sixth Edition written by Kenneth R. Piña and published by Food and Drug Law Institute. This book was released on 2017-08-21 with total page 618 pages. Available in PDF, EPUB and Kindle. Book excerpt: A Practical Guide to FDA's Food and Drug Law and Regulation provides an introduction to the laws and regulations governing development, marketing, and sale of food, medical products, tobacco, and cosmetics. Structured to serve as a reference and as a teaching tool, each chapter builds sequentially from the last, while providing an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. Written in real-world language, the book offers practical legal/regulatory fundamentals for use by a wide range of people interested in the FDA legal and regulatory scheme. This book is a standard text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including a U.S. Supreme Court opinion). This Sixth Edition incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances. It also incorporates important changes that have resulted from recent court opinions and administrative enforcement actions.
