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The FDA for Doctors

  • Book
  • © 2014

Overview

Authors:
  1. William H. Eaglstein

    1. Chairman Emeritus, Department of Dermatology and Cutaneous Surgery, The University of Miami Miller School of Medicine, Miami, USA

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  • Provides readers with an in-depth understanding of the FDA and those issues related to their practice and to society in general

  • Represents an introductory overview written from a physician’s perspective for physicians

  • Contains detailed explanation of nomenclature and definitions

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Table of contents (24 chapters)

  1. Front Matter

    Pages i-xi
    Download chapter PDF

  2. Doctors and the FDA

    • William H. Eaglstein
    Pages 1-3

  3. What Are Drugs?

    • William H. Eaglstein
    Pages 5-13

  4. What Are Devices?

    • William H. Eaglstein
    Pages 15-18

  5. What Are Biologics, Biological Products and Biological Drugs?

    • William H. Eaglstein
    Pages 19-20

  6. What Are Combination Products?

    • William H. Eaglstein
    Pages 21-23

  7. What Are Dietary Supplements and Nutraceuticals?

    • William H. Eaglstein
    Pages 25-27

  8. What Are Cosmetics and Cosmeceuticals?

    • William H. Eaglstein
    Pages 29-31

  9. What Is the FDA and What Does It Do?

    • William H. Eaglstein
    Pages 33-35

  10. Foods, Doctors and the FDA

    • William H. Eaglstein
    Pages 37-38

  11. The FDA Approval Process and Drug Development

    • William H. Eaglstein
    Pages 39-51

  12. The New Drug Application (NDA), the Investigative New Drug Exemption (IND) and the General Drug Approval Pathway

    • William H. Eaglstein
    Pages 53-54

  13. FDA and Tobacco Products

    • William H. Eaglstein
    Pages 55-56

  14. FDA Advisory Committees

    • William H. Eaglstein
    Pages 57-58

  15. FDA, Labels and Labeling for Medical Products

    • William H. Eaglstein
    Pages 59-60

  16. FDA and Product Names

    • William H. Eaglstein
    Pages 61-62

  17. FDA and Promotion and Advertising

    • William H. Eaglstein
    Pages 63-66

  18. Off-Label Use

    • William H. Eaglstein
    Pages 67-68

  19. Additional Drug Approval Pathways and Expanded Access (Treatment INDs); and Personal Importation of Unapproved Drugs

    • William H. Eaglstein
    Pages 69-72

  20. FDA Exclusivity and Patents

    • William H. Eaglstein
    Pages 73-75
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Keywords

About this book

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.

Reviews

“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)

Authors and Affiliations

  • Chairman Emeritus, Department of Dermatology and Cutaneous Surgery, The University of Miami Miller School of Medicine, Miami, USA

    William H. Eaglstein

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.

Bibliographic Information

  • Book Title: The FDA for Doctors

  • Authors: William H. Eaglstein

  • DOI: https://doi.org/10.1007/978-3-319-08362-9

  • Publisher: Springer Cham

  • eBook Packages: Medicine, Medicine (R0)

  • Copyright Information: Springer International Publishing Switzerland 2014

  • Softcover ISBN: 978-3-319-08361-2Published: 19 August 2014

  • eBook ISBN: 978-3-319-08362-9Published: 05 August 2014

  • Edition Number: 1

  • Number of Pages: XI, 97

  • Number of Illustrations: 1 illustrations in colour

  • Topics: Medicine/Public Health, general, Health Administration, Pharmacoeconomics and Health Outcomes

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