The FDA for Doctors [recurso electrónico

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. "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 US 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 device companies - Font no determinada Front Matter....Pages i-xi Doctors and the FDA....Pages 1-3 What Are Drugs?....Pages 5-13 What Are Devices?....Pages 15-18 What Are Biologics, Biological Products and Biological Drugs?....Pages 19-20 What Are Combination Products?....Pages 21-23 What Are Dietary Supplements and Nutraceuticals?....Pages 25-27 What Are Cosmetics and Cosmeceuticals?....Pages 29-31 What Is the FDA and What Does It Do?....Pages 33-35 Foods, Doctors and the FDA....Pages 37-38 The FDA Approval Process and Drug Development....Pages 39-51 The New Drug Application (NDA), the Investigative New Drug Exemption (IND) and the General Drug Approval Pathway....Pages 53-54 FDA and Tobacco Products....Pages 55-56 FDA Advisory Committees....Pages 57-58 FDA, Labels and Labeling for Medical Products....Pages 59-60 FDA and Product Names....Pages 61-62 FDA and Promotion and Advertising....Pages 63-66 Off-Label Use....Pages 67-68 Additional Drug Approval Pathways and Expanded Access (Treatment INDs); and Personal Importation of Unapproved Drugs....Pages 69-72 FDA Exclusivity and Patents....Pages 73-75 Adverse Event Reporting, Pharmacovigilance and FDA....Pages 77-79 FDA Rule Making and Guidances....Pages 81-82 Enforcement and Warning Letters....Pages 83-84 The FDA, Politics and Criticism....Pages 85-87 Brief History of the FDA....Pages 89-93 Back Matter....Pages 95-97 "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. 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 totherapeutics 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 device companies"--Back cover