BookWilliam H. Eaglstein.
Summary: "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.