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.
