The FDA for Doctors

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.

Table of Contents:
Introduction - The FDA, Doctors and the Practice of Medicine.- Drugs.- Devices.- Biologics.- Combination Products.- Supplements and Neutraceuticals.- Foods.- Cosmetics and Cosmeceuticals.- The FDA (history, organization, budgets).- The Approval Process (including Phases 1-4, advisory committees, Guidances and personal medicine).- The FDA and Promotion and Advertising.- The FDA and Drug Names.- The FDA , Politics and the Public.

About the Author :
Dr. Eaglstein is a medical graduate of the University of Missouri, Columbia. After an internship at Kings County Hospital in Brooklyn he completed his dermatology training at the University of Miami follow which he served in the U.S. Navy Medical Corps. He is a past professor and chairman of dermatology at the University of Pittsburgh and the University of Miami, where he is currently chairman emeritus. Since 2004 he has worked in industry at Ivax Pharmaceuticals( President of Ivax Derm), Teva and Stiefel Pharmaceuticals ( Vice President of Research ) and Stiefel a GSK company (Vice President of New Product Assessment and External Research). He is currently an independent consultant, serves on the National Institutes of Arthritis, Musculoskeletal and Skin (NIAMS) Clinical Trials Review Committee and is a volunteer for the Stanford School of Medicine SPARK program. Dr. Eaglstein has been a Robert Wood Johnson Health Policy Fellow, Chairman of an FDA skin advisory panel, Consultant to the FDA OTC division and on the NIAMS NIH National Advisory Panel. He continues his interest in health and regulatory policy. His medical/scientific interests include wound healing, wound care, drug development, skin infections, UV inflammation and inflammatory diseases such as psoriasis and acne.

Review :

“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)