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Table of contents

  1. Front Matter
    Pages i-xi
  2. William H. Eaglstein
    Pages 1-3
  3. William H. Eaglstein
    Pages 5-13
  4. William H. Eaglstein
    Pages 15-18
  5. William H. Eaglstein
    Pages 21-23
  6. William H. Eaglstein
    Pages 25-27
  7. William H. Eaglstein
    Pages 29-31
  8. William H. Eaglstein
    Pages 33-35
  9. William H. Eaglstein
    Pages 37-38
  10. William H. Eaglstein
    Pages 39-51
  11. William H. Eaglstein
    Pages 55-56
  12. William H. Eaglstein
    Pages 57-58
  13. William H. Eaglstein
    Pages 59-60
  14. William H. Eaglstein
    Pages 61-62
  15. William H. Eaglstein
    Pages 63-66
  16. William H. Eaglstein
    Pages 67-68
  17. William H. Eaglstein
    Pages 73-75
  18. William H. Eaglstein
    Pages 77-79
  19. William H. Eaglstein
    Pages 81-82
  20. William H. Eaglstein
    Pages 83-84
  21. William H. Eaglstein
    Pages 85-87
  22. William H. Eaglstein
    Pages 89-93
  23. Back Matter
    Pages 95-97

About this book

Introduction

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. For example, how many realize that the US is one of only two countries which allow direct-to-consumer drug advertising, which is regulated by FDA?  Or that FDA itself advertises to try to prevent young people from smoking cigarettes, and that all proprietary drug names must be approved by FDA?  How many doctors or other readers are familiar with the formal definition distinguishing drugs from devices and the importance this has for development costs and for our knowledge about the ultimate products?   How many know how much nutritional supplements are regulated by FDA?

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 to therapeutics 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.    

Keywords

FDA Advisory Committees Food and Drug Administration Medical devices Medical drugs

Authors and affiliations

  • William H. Eaglstein
    • 1
  1. 1.Chairman Emeritus, Department of Dermatology and Cutaneous SurgeryThe University of Miami Miller School of MedicineMiamiUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-08362-9
  • Copyright Information Springer International Publishing Switzerland 2014
  • Publisher Name Springer, Cham
  • eBook Packages Medicine
  • Print ISBN 978-3-319-08361-2
  • Online ISBN 978-3-319-08362-9
  • Buy this book on publisher's site