Inside the FDA

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Publisher : John Wiley & Sons
ISBN 13 : 1118040066
Total Pages : 393 pages
Book Rating : 4.1/5 (18 download)

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Book Synopsis Inside the FDA by : Fran Hawthorne

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.

FDA in the Twenty-First Century

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Publisher : Columbia University Press
ISBN 13 : 0231540078
Total Pages : 499 pages
Book Rating : 4.2/5 (315 download)

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Book Synopsis FDA in the Twenty-First Century by : Holly Fernandez Lynch

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.

Drugs and the FDA

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Publisher : MIT Press
ISBN 13 : 0262548399
Total Pages : 319 pages
Book Rating : 4.2/5 (625 download)

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Book Synopsis Drugs and the FDA by : Mikkael A. Sekeres

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.

Protecting America's Health

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Publisher : UNC Press Books
ISBN 13 : 9780807855829
Total Pages : 0 pages
Book Rating : 4.8/5 (558 download)

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Book Synopsis Protecting America's Health by : Philip J. Hilts

Download or read book Protecting America's Health written by Philip J. Hilts and published by UNC Press Books. This book was released on 2004 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

FDA Approved Animal Drug Products

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Publisher :
ISBN 13 :
Total Pages : 144 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis FDA Approved Animal Drug Products by :

Download or read book FDA Approved Animal Drug Products written by and published by . This book was released on 1998 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt:

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

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Author :
Publisher :
ISBN 13 : 9781935065876
Total Pages : 672 pages
Book Rating : 4.0/5 (658 download)

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Book Synopsis A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition by : Stephen M. Kanovsky

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.

FDA--failure, Deception, Abuse

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Publisher :
ISBN 13 : 9781607660019
Total Pages : 0 pages
Book Rating : 4.6/5 (6 download)

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Book Synopsis FDA--failure, Deception, Abuse by : From Life Extension Magazine

Download or read book FDA--failure, Deception, Abuse written by From Life Extension Magazine and published by . This book was released on 2010 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: For the past 21 years, Life Extension magazine has compiled evidence indicating that conventional medicine is the leading cause of death in our country-and the US Food and Drug Administration is largely responsible. They deny the introduction of life-saving therapies, cause drug prices to be beyond the means of most Americans, approve lethal prescription drugs that kill, censor scientific and medical information that would let consumers protect their health, and actively mislead the public.

Fight for Your Health

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Publisher : Take Charge (Truth in Wellness
ISBN 13 : 9781933927176
Total Pages : 0 pages
Book Rating : 4.9/5 (271 download)

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Book Synopsis Fight for Your Health by : Byron J. Richards

Download or read book Fight for Your Health written by Byron J. Richards and published by Take Charge (Truth in Wellness. This book was released on 2006-09-14 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

FDA Regulatory Affairs

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Publisher : CRC Press
ISBN 13 : 1040061974
Total Pages : 466 pages
Book Rating : 4.0/5 (4 download)

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Book Synopsis FDA Regulatory Affairs by : Douglas J. Pisano

Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 466 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in

Quality Risk Management in the FDA-Regulated Industry

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Publisher : Quality Press
ISBN 13 : 0873898346
Total Pages : 289 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis Quality Risk Management in the FDA-Regulated Industry by : José Rodríguez Pérez

Download or read book Quality Risk Management in the FDA-Regulated Industry written by José Rodríguez Pérez and published by Quality Press. This book was released on 2012-06-12 with total page 289 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Stop the FDA

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Publisher : Smart Publications
ISBN 13 : 9780962741883
Total Pages : 196 pages
Book Rating : 4.7/5 (418 download)

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Book Synopsis Stop the FDA by : John Morgenthaler

Download or read book Stop the FDA written by John Morgenthaler and published by Smart Publications. This book was released on 1992 with total page 196 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Handbook of Investigation and Effective CAPA Systems

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Publisher : Quality Press
ISBN 13 : 1636940129
Total Pages : 152 pages
Book Rating : 4.6/5 (369 download)

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Book Synopsis Handbook of Investigation and Effective CAPA Systems by : Jose (Pepe) Rodriguez-Perez

Download or read book Handbook of Investigation and Effective CAPA Systems written by Jose (Pepe) Rodriguez-Perez and published by Quality Press. This book was released on 2022-02-15 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt: Worldwide regulatory agencies perform many inspections annually, and all too often investigation and CAPA system violations are at the top of the list of infractions. Life-sciences regulated companies (not only FDA-regulated ones) must ensure their investigation and CAPA systems look beyond the ‘usual suspects' to identify other quality issues in order to minimize risks (including safe ones) and reduce costs. Enhancements to this third edition include: A new section linking the investigation and CAPA programs with the overall quality culture of the company Fully updated, current versions of regulations including U.S. FDA, EU, ISO 9001, and ISO 13485 Updated inspectional observations from the U.S. FDA and U.K. MHRA A revised investigation and CAPA processes chapter, which has an improved barrier analysis section, including detailed flowcharts describing the barrier analysis process New charts and information related to the investigation of human errors; the human factor section includes information about training and competence A new chapter devoted to analytical laboratory investigations, including a section covering the invalidation of testing results Updated forms and examples of the different elements of the investigation and CAPA plan, including new case studies; a revised diagnostic tool used for investigating human error Jose(Pepe) Rodrguez-Perez, PhD, is president of Business Excellence Consulting, Inc., (BEC), a Puerto Rico-based, consulting, training, and remediation firm that focuses on the areas of regulatory compliance, FDA-regulatory training, and risk management. He is a biologist with a doctoral degree in biology from the University of Granada (Spain). Over his career, he has served as an educator, a technical services manager, and as a science advisor to the FDA.

An Overview of FDA Regulated Products

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Publisher : Academic Press
ISBN 13 : 0128111569
Total Pages : 292 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis An Overview of FDA Regulated Products by : Eunjoo Pacifici

Download or read book An Overview of FDA Regulated Products written by Eunjoo Pacifici and published by Academic Press. This book was released on 2018-06-13 with total page 292 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Unsafe at Any Meal

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Publisher : Square One Publishers, Inc.
ISBN 13 : 0757054366
Total Pages : 272 pages
Book Rating : 4.7/5 (57 download)

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Book Synopsis Unsafe at Any Meal by : Dr. Renee Joy Dufault

Download or read book Unsafe at Any Meal written by Dr. Renee Joy Dufault and published by Square One Publishers, Inc.. This book was released on 2017-05-04 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: Each year, Americans consume hundreds of food products that contain truly dangerous compounds, including heavy metals, pesticides, and other harmful additives—with the blessing of the FDA. Why is this happening and why haven’t you heard about it? In Unsafe at Any Meal, Dr. Renee Dufault, former food investigator for the Food and Drug Administration, provides the startling answers. While at the FDA, Dr. Dufault discovered that mercury—a highly toxic metal—was contaminating the plumbing systems of many food manufacturing plants. Upon further examination, she discovered that the same mercury was also evident in a number of processed foods commonly sold in supermarkets. When Dr. Dufault revealed these disturbing findings to her superiors, she was told to stop her investigation. Her continued efforts to raise the issue always met with a dead end, so she chose to take an early retirement from the FDA. Dr. Dufault then devoted her energy to making the public aware of the insidious dangers that contaminate our food. In 2010, she founded an organization of scientists to study the scope of this problem and has published numerous research articles on the topic with little fanfare. To expose what still seems to be a well-kept secret by the FDA, she has written Unsafe at Any Meal to provide consumers with the information they need to know. The book begins with the author’s story leading up to the creation of this work. It then describes the various toxic substances that are most commonly found in our food supply, and explains how they affect your genes, health, and the surrounding environment. After examining the Standard American Diet, which is sorely lacking in disease-preventing nutrients, it discusses the country’s trend toward consuming a skyrocketing amount of ingredients that can contain heavy metals. It further shows how exposure to these heavy metals can contribute to conditions such as ADHD or autism. Also included is a helpful guide to reading food labels, recognizing misleading marketing tactics, and knowing what to look for—and what to look out for—in the aisles of your grocery store. Over fifty years ago, Rachel Carson’s book Silent Spring exposed the dangers of DDT in our food supply. Unfortunately, it seems that the problem of food contamination has actually become worse. Backed by research and first-hand experience, Dr. Dufault reveals how the FDA has failed us, and outlines how you can protect yourself and your family by knowing what to avoid and by filling your kitchen with food that is clear of toxins.

FDA Regulatory Affairs

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Publisher : CRC Press
ISBN 13 : 1841849200
Total Pages : 401 pages
Book Rating : 4.8/5 (418 download)

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Book Synopsis FDA Regulatory Affairs by : David Mantus

Download or read book FDA Regulatory Affairs written by David Mantus and published by CRC Press. This book was released on 2014-02-28 with total page 401 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDA Regulatory Affairs is a roadmap to prescription drug, biologics, and medical device development in the United States. Written in plain English, the concise and jargon-free text demystifies the inner workings of the US Food and Drug Administration (FDA) and facilitates an understanding of how the agency operates with respect to compliance and product approval, including clinical trial exemptions, fast track status, advisory committee procedures, and more. The Third Edition of this highly successful publication: Examines the harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations on human drug, biologics and device development, research, manufacturing, and marketing Includes contributions from experts at organizations such as the FDA, National Institutes of Health (NIH), and PAREXEL Focuses on the new drug application (NDA) process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements Provides updates to the FDA Safety and Innovation Act (FDASIA), incorporating pediatric guidelines and follow-on biologics regulations from the 2012 Prescription Drug User Fee Act (PDUFA) V Explains current FDA inspection processes, enforcement options, and how to handle FDA meetings and required submissions Co-edited by an industry leader (Mantus) and a respected academic (Pisano), FDA Regulatory Affairs, Third Edition delivers a compilation of the selected US laws and regulations as well as a straightforward commentary on the FDA product approval process that’s broadly useful to both business and academia.

The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices

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Author :
Publisher : Quality Press
ISBN 13 : 0873897404
Total Pages : 355 pages
Book Rating : 4.8/5 (738 download)

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Book Synopsis The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices by : Amiram Daniel

Download or read book The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices written by Amiram Daniel and published by Quality Press. This book was released on 2008-01-01 with total page 355 pages. Available in PDF, EPUB and Kindle. Book excerpt: How have recent changes in domestic and international regulations affected quality management in the development and marketing of medical devices in the US and abroad? Consultants Daniel and Kimmelman take a close look at the Quality System Regulation (QsReg), the ISO 13485: 2003 standard and the ISO/TR 14969: 2004 guidance document as well as a number of US Food and Drug Administration (FDA) and Global Harmonization Task Force (GHTF) guidance documents. The authors provide extensive commentary and notes an update their material to include such topics as the incorporation of principles of risk management into the medical device organizations' quality management systems (QMSs) and considerations of combination products. Daniel and Kimmelman include full coverage of the QSReg requirements, descriptions of comparable requirements in the ISO documents, excerpts of the FDA's responses to the QSReg preamble and excerpts from FDA guidance documents related to QMSs.

FDA's Drug Review Process and the Package Label

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Author :
Publisher : Academic Press
ISBN 13 : 0128146486
Total Pages : 671 pages
Book Rating : 4.1/5 (281 download)

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Book Synopsis FDA's Drug Review Process and the Package Label by : Tom Brody

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 2017-12-01 with total page 671 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