Chapter 20. The Regulation of Drug Products by the United States Food and Drug Administration

  1. John P Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM1,
  2. John O'Grady MD, FRCP, FFPM, FBIRA, MRCPath2
  1. Peter Barton Hutt

Published Online: 25 OCT 2007

DOI: 10.1002/9780470987391.ch20

Book Title

The Textbook of Pharmaceutical Medicine, Fifth Edition

The Textbook of Pharmaceutical Medicine, Fifth Edition

Additional Information

How to Cite

Hutt, P. B. (2007) The Regulation of Drug Products by the United States Food and Drug Administration, in The Textbook of Pharmaceutical Medicine, Fifth Edition (eds J. P. Griffin and J. O'Grady), Blackwell Publishing Ltd, Oxford, UK. doi: 10.1002/9780470987391.ch20

Editor Information

  1. 1

    Director, Asklepieion Consultancy Ltd., Visiting Professor, University of Surrey Postgraduate Medical School, Former Director, Association of the British Pharmaceutical Industry, London, Formerly Professional Head of the Medicines Division, DHSS, London

  2. 2

    Visiting Professor of Clinical Pharmacology, University of London

Publication History

  1. Published Online: 25 OCT 2007
  2. Published Print: 15 DEC 2005

ISBN Information

Print ISBN: 9780727918406

Online ISBN: 9780470987391

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CHAPTER TOOLS

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Keywords:

  • medicinal products;
  • pharmaceutical regulations;
  • food and drug administration;
  • drug regulation statutes;
  • united states

Summary

This chapter contains sections titled:

  • Introduction

  • Regulatory Framework

  • FDA History

  • Historical Overview of Drug Regulation Statutes

  • Other Pharmaceutical Products

  • Two Classes of Drug Products

  • Regulation of Non-prescription Drugs

  • Regulation of prescription drugs

  • Biological Drugs

  • Enforcement

  • Conclusion

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