Inside The Fda
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| Author | : Fran Hawthorne |
| Publisher | : John Wiley & Sons |
| Total Pages | : 393 |
| Release | : 2010-12-13 |
| Genre | : Business & Economics |
| ISBN | : 1118040066 |
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 | : Holly Fernandez Lynch |
| Publisher | : Columbia University Press |
| Total Pages | : 499 |
| Release | : 2015-09-08 |
| Genre | : Business & Economics |
| ISBN | : 0231540078 |
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 | : Mikkael A. Sekeres |
| Publisher | : MIT Press |
| Total Pages | : 319 |
| Release | : 2024-02-06 |
| Genre | : Medical |
| ISBN | : 0262548399 |
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 | : Philip J. Hilts |
| Publisher | : UNC Press Books |
| Total Pages | : 0 |
| Release | : 2004 |
| Genre | : Aliments |
| ISBN | : 9780807855829 |
Emerging out of Theodore Roosevelt's desire to civilize capitalism, the Food and Drug Administration was created to stop the trade in adulterated meats and quack drugs. This history of the agency takes readers back to its beginnings, and makes startlingly clear the essential role the FDA has played in maintaining the quality of life and health to which the American public has long been accustomed.
| Author | : Suzanne Parisian |
| Publisher | : |
| Total Pages | : 680 |
| Release | : 2001 |
| Genre | : |
| ISBN | : |
Parisian (formerly of the Food and Drug Administration, now a consultant) offers a guide to preparing clinical trials intended for submission to the FDA and for marketing purposes. She also provides an organizational map of the agency, outlining its requirements, procedures, and history, with an emphasis on the implications for medical practice, manufacturing, and marketing. The logic governing the agency and the rationale by which it makes its decisions are included in the coverage. Annotation copyrighted by Book News Inc., Portland, OR.
| Author | : Byron J. Richards |
| Publisher | : Take Charge (Truth in Wellness |
| Total Pages | : 0 |
| Release | : 2006-09-14 |
| Genre | : Medical |
| ISBN | : 9781933927176 |
Fight for Your Health: Exposing the FDA's Betrayal of America is a stunning exposé into the secret world of the FDA, Wall Street, and drug companies. At stake is the health and well-being of all Americans. Adverse reactions, even deaths, are hidden while dangerous drugs are pushed on Americans, especially children simply for profit. The FDA is actively attacking health freedom and seeking to eliminate natural health options. Arm yourself with invaluable information that will help you take charge of your health: + FDA working on behalf of drug companies + Mind-control through "mental health" + The true Codex story; health option control + Globalization at the expense of Americans + Poisoning us with our food and water + Your DNA in government computers
| Author | : |
| Publisher | : |
| Total Pages | : 144 |
| Release | : 1998 |
| Genre | : Veterinary drugs |
| ISBN | : |
| Author | : John Morgenthaler |
| Publisher | : Smart Publications |
| Total Pages | : 196 |
| Release | : 1992 |
| Genre | : Health & Fitness |
| ISBN | : 9780962741883 |
| Author | : Stephen M. Kanovsky |
| Publisher | : |
| Total Pages | : 672 |
| Release | : 2020-09 |
| Genre | : Drugs |
| ISBN | : 9781935065876 |
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 | : José Rodríguez Pérez |
| Publisher | : Quality Press |
| Total Pages | : 289 |
| Release | : 2012-06-12 |
| Genre | : Business & Economics |
| ISBN | : 0873898346 |
Risk management principles are effectively utilized in many areas of business and government, including finance, insurance, occupational safety, and public health, and by agencies regulating these industries. The U.S. Food and Drug Administration (FDA) and its worldwide counterparts are responsible for protecting public health by ensuring the safety and effectiveness of the drugs and medical devices. Regulators must decide whether the benefits of a specific product for patients and users outweigh its risk, while recognizing that absolute safety (or zero risk) is not achievable. Every product and every process has an associated risk. Although there are some examples of the use of quality risk management in the FDA-regulated industry today, they are limited and do not represent the full contribution that risk management has to offer. The present FDA focus on risk-based determination is requiring that the regulated industries improve dramatically their understanding and capability of hazard control concepts. In addition, the importance of quality systems has been recognized in the life sciences industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system. The purpose of this book is to offer a systematic and very comprehensive approach to quality risk management. It will assist medical and food product manufacturers with the integration of a risk management system or risk management principles and activities into their existing quality management system by providing practical explanations and examples. The appropriate use of quality risk management can facilitate compliance with regulatory requirements such as good manufacturing practices or good laboratory practices. The content of this book will provide FDA-regulated manufacturers with a framework within which experience, insight, and judgment are applied systematically to manage the risks associated with their products. Manufacturers in other industries may use it as an informative guidance in developing and maintaining a risk management system and process. The two appendices add even more insight: Appendix A contains general examples of risk management, while Appendix B includes 10 case studies illustrating real examples of the quality risk management process across the medical product arena.
