The FDA for Doctors
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Beschreibung
This book explains the Food and Drug Administration (FDA) as an institution and provides understanding of its nomenclature, societal role, policies, goals and challenges. While many readers will have some knowledge of the FDA, few have an appreciation of the many specific areas of FDA authority. For example, how many realize that the US is one of only two countries which allow direct-to-consumer drug advertising, which is regulated by FDA? Or that FDA itself advertises to try to prevent young people from smoking cigarettes, and that all proprietary drug names must be approved by FDA? How many doctors or other readers are familiar with the formal definition distinguishing drugs from devices and the importance this has for development costs and for our knowledge about the ultimate products? How many know how much nutritional supplements are regulated by FDA?
The FDA for Doctors is not for those looking for detailed instruction on dealing with the FDA or its operations. Rather, it is written by a doctor with doctors in mind, with the hope that the information in this book will make physicians, and other readers, more thoughtful and insightful, especially with regards to therapeutics and the many broad societal issues underlying FDA’s activities.
With over 40 years of experience as a clinical investigator in many trials done for FDA registration, the author has been a member of and chaired an FDA advisory committee, and has been a consultant to several divisions of the FDA. He has also had the opportunity to serve on the U.S. Senate Labor Committee, helping with its FDA oversight activities. In addition to a long academic medical career the author has been a consultant to and a full time employee of drug and devicecompanies.
Many doctors want to know more about the FDA not only so that they might better understand the issues and how they are related to their practice, such as off label-drug usage, but also to enrich their professional lives and allow them to more deeply understand the many FDA related articles written in the popular press. It is further based on the notion that doctors prefer a formal way to learn about FDA. The Agency is a truly vast subject engaging thousands of lawyers, regulators, scientists, physicians, writers, legislators and many others directly and indirectly. This book is an introductory overview written from a physician’s perspective for physicians. It is organized along lines that emphasize issues most interesting to physicians. Much of it deals with nomenclature and definitions, since as is true of all fields, one must understand the special concepts and vocabulary of the field.
Provides readers with an in-depth understanding of the FDA and those issues related to their practice and to society in general Represents an introductory overview written from a physician’s perspective for physicians Contains detailed explanation of nomenclature and definitions
Autor*in
William H. Eaglstein
Themen in »The FDA for Doctors«
FDA Advisory Committees Food and Drug Administration Medical devices Medical drugs pharmacoeconomics
Stimmen zu »The FDA for Doctors«
“This is an excellent book that explores the question and provides many more details about the FDA. … The physician, to whom this book is directed, will learn about the regulatory process for drugs and how devices differ from drugs, nutraceuticals, and cosmeceuticals … . Dermatologists will find this book to be a fascinating excursion into another part of contemporary medicine.” (Jennifer L. Parish, SKINmed, Vol. 13 (1), January-February, 2015)
“The audience includes clinicians, policymakers, and anyone else who has an interest in how a medication comes to the marketplace. … it does an outstanding job of helping clinicians explain to their patients what they hear in the media and how a medication or device comes to market and how a medication might actually be removed from the market once FDA approval has been obtained.” (Vincent F. Carr, Doody's Book Reviews, December, 2014)
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