The FDA for Doctors [Paperback]

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 physicians 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.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.

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 l&