An Overview of FDA Regulated Products
An Overview of FDA Regulated Products

Author: Eunjoo Pacifici

Publisher: Academic Press

Published: 2018-06-13

Total Pages: 292

ISBN-13: 0128111569

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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

Assessing the Use of Agent-Based Models for Tobacco Regulation
Assessing the Use of Agent-Based Models for Tobacco Regulation

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2015-07-17

Total Pages: 269

ISBN-13: 0309317258

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Tobacco consumption continues to be the leading cause of preventable disease and death in the United States. The Food and Drug Administration (FDA) regulates the manufacture, distribution, and marketing of tobacco products - specifically cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco - to protect public health and reduce tobacco use in the United States. Given the strong social component inherent to tobacco use onset, cessation, and relapse, and given the heterogeneity of those social interactions, agent-based models have the potential to be an essential tool in assessing the effects of policies to control tobacco. Assessing the Use of Agent-Based Models for Tobacco Regulation describes the complex tobacco environment; discusses the usefulness of agent-based models to inform tobacco policy and regulation; presents an evaluation framework for policy-relevant agent-based models; examines the role and type of data needed to develop agent-based models for tobacco regulation; provides an assessment of the agent-based model developed for FDA; and offers strategies for using agent-based models to inform decision making in the future.

A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition
A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition

Author: Stephen M. Kanovsky

Publisher:

Published: 2020-09

Total Pages: 672

ISBN-13: 9781935065876

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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.

A Question Of Intent
A Question Of Intent

Author: David Kessler

Publisher: Public Affairs

Published: 2001

Total Pages: 518

ISBN-13: 9781586481216

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Former FDA commissioner David Kessler guides the reader through a legal thriller, telling the story of the FDA's fight with big tobacco.

Tobacco War
Tobacco War

Author: Stanton A. Glantz

Publisher: Univ of California Press

Published: 2000-05-10

Total Pages: 499

ISBN-13: 0520924681

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Tobacco War charts the dramatic and complex history of tobacco politics in California over the past quarter century. Beginning with the activities of a small band of activists who, in the 1970s, put forward the radical notion that people should not have to breathe second-hand tobacco smoke, Stanton Glantz and Edith Balbach follow the movement through the 1980s, when activists created hundreds of city and county ordinances by working through their local officials, to the present--when tobacco is a highly visible issue in American politics and smoke-free restaurants and bars are a reality throughout the state. The authors show how these accomplishments rest on the groundwork laid over the past two decades by tobacco control activists who have worked across the U.S. to change how people view the tobacco industry and its behavior. Tobacco War is accessibly written, balanced, and meticulously researched. The California experience provides a graphic demonstration of the successes and failures of both the tobacco industry and public health forces. It shows how public health advocates slowly learned to control the terms of the debate and how they discovered that simply establishing tobacco control programs was not enough, that constant vigilance was necessary to protect programs from a hostile legislature and governor. In the end, the California experience proves that it is possible to dramatically change how people think about tobacco and the tobacco industry and to rapidly reduce tobacco consumption. But California's experience also demonstrates that it is possible to run such programs successfully only as long as the public health community exerts power effectively. With legal settlements bringing big dollars to tobacco control programs in every state, this book is must reading for anyone interested in battling and beating the tobacco industry.

Scientific Standards for Studies on Modified Risk Tobacco Products
Scientific Standards for Studies on Modified Risk Tobacco Products

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2012-04-19

Total Pages: 370

ISBN-13: 0309223989

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Smoking-related diseases kill more Americans than alcohol, illegal drugs, murder and suicide combined. The passage of the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA authority to regulate "modified risk tobacco products" (MRTPs), tobacco products that are either designed or advertised to reduce harm or the risk of tobacco-related disease. MRTPs must submit to the FDA scientific evidence to demonstrate the product has the potential to reduce tobacco related harms as compared to conventional tobacco products. The IOM identifies minimum standards for scientific studies that an applicant would need to complete to obtain an order to market the product from the FDA.

Reducing Tobacco-Related Cancer Incidence and Mortality
Reducing Tobacco-Related Cancer Incidence and Mortality

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2013-04-16

Total Pages: 131

ISBN-13: 0309264049

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Tobacco use is the leading cause of preventable death in United States, causing more than 440,000 deaths annually and resulting in $193 billion in health-related economic losses each year-$96 billion in direct medical costs and $97 billion in lost productivity. Since the first U.S. Surgeon General's report on smoking in 1964, more than 29 Surgeon General's reports, drawing on data from thousands of studies, have documented the overwhelming and conclusive biologic, epidemiologic, behavioral, and pharmacologic evidence that tobacco use is deadly. This evidence base links tobacco use to the development of multiple types of cancer and other life-threatening conditions, including cardiovascular and respiratory diseases. Smoking accounts for at least 30 percent of all cancer deaths, and 80 percent of lung cancer deaths. Despite the widespread agreement on the dangers of tobacco use and considerable success in reducing tobacco use prevalence from over 40 percent at the time of the 1964 Surgeon General's report to less than 20 percent today, recent progress in reducing tobacco use has slowed. An estimated 18.9 percent of U.S. adults smoke cigarettes, nearly one in four high school seniors smoke, and 13 percent of high school males use smokeless tobacco products. In recognition that progress in combating cancer will not be fully achieved without addressing the tobacco problem, the National Cancer Policy Forum of the Institute of Medicine (IOM) convened a public workshop, Reducing Tobacco-Related Cancer Incidence and Mortality, June 11-12, 2012 in Washington, DC. In opening remarks to the workshop participants, planning committee chair Roy Herbst, professor of medicine and of pharmacology and chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital, described the goals of the workshop, which were to examine the current obstacles to tobacco control and to discuss potential policy, outreach, and treatment strategies that could overcome these obstacles and reduce tobacco-related cancer incidence and mortality. Experts explored a number of topics, including: the changing demographics of tobacco users and the changing patterns of tobacco product use; the influence of tobacco use on cancer incidence and cancer treatment outcomes; tobacco dependence and cessation programs; federal and state level laws and regulations to curtail tobacco use; tobacco control education, messaging, and advocacy; financial and legal challenges to tobacco control efforts; and research and infrastructure needs to support tobacco control strategies, reduce tobacco related cancer incidence, and improve cancer patient outcomes. Reducing Tobacco-Related Cancer Incidence and Mortality summarizes the workshop.

Secondhand Smoke Exposure and Cardiovascular Effects
Secondhand Smoke Exposure and Cardiovascular Effects

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2010-02-21

Total Pages: 240

ISBN-13: 0309138396

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Data suggest that exposure to secondhand smoke can result in heart disease in nonsmoking adults. Recently, progress has been made in reducing involuntary exposure to secondhand smoke through legislation banning smoking in workplaces, restaurants, and other public places. The effect of legislation to ban smoking and its effects on the cardiovascular health of nonsmoking adults, however, remains a question. Secondhand Smoke Exposure and Cardiovascular Effects reviews available scientific literature to assess the relationship between secondhand smoke exposure and acute coronary events. The authors, experts in secondhand smoke exposure and toxicology, clinical cardiology, epidemiology, and statistics, find that there is about a 25 to 30 percent increase in the risk of coronary heart disease from exposure to secondhand smoke. Their findings agree with the 2006 Surgeon General's Report conclusion that there are increased risks of coronary heart disease morbidity and mortality among men and women exposed to secondhand smoke. However, the authors note that the evidence for determining the magnitude of the relationship between chronic secondhand smoke exposure and coronary heart disease is not very strong. Public health professionals will rely upon Secondhand Smoke Exposure and Cardiovascular Effects for its survey of critical epidemiological studies on the effects of smoking bans and evidence of links between secondhand smoke exposure and cardiovascular events, as well as its findings and recommendations.

The Cigarette Century
The Cigarette Century

Author: Allan M. Brandt

Publisher: Basic Books

Published: 2009-01-06

Total Pages: 644

ISBN-13: 0786721901

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The invention of mass marketing led to cigarettes being emblazoned in advertising and film, deeply tied to modern notions of glamour and sex appeal. It is hard to find a photo of Humphrey Bogart or Lauren Bacall without a cigarette. No product has been so heavily promoted or has become so deeply entrenched in American consciousness. And no product has received such sustained scientific scrutiny. The development of new medical knowledge demonstrating the dire harms of smoking ultimately shaped the evolution of evidence-based medicine. In response, the tobacco industry engineered a campaign of scientific disinformation seeking to delay, disrupt, and suppress these studies. Using a massive archive of previously secret documents, historian Allan Brandt shows how the industry pioneered these campaigns, particularly using special interest lobbying and largesse to elude regulation. But even as the cultural dominance of the cigarette has waned and consumption has fallen dramatically in the U.S., Big Tobacco remains securely positioned to expand into new global markets. The implications for the future are vast: 100 million people died of smoking-related diseases in the 20th century; in the next 100 years, we expect 1 billion deaths worldwide.