Chapter 21. The US FDA in the Drug Development, Evaluation and Approval Process
- John P Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM1,
- John O'Grady MD, FRCP, FFPM, FBIRA, MRCPath2
Published Online: 25 OCT 2007
DOI: 10.1002/9780470987391.ch21
© 2006 by Blackwell Publishing Ltd.
Book Title
The Textbook of Pharmaceutical Medicine, Fifth Edition
Additional Information
How to Cite
Spivey, R. N., Jones, J. K., Wardell, W. and Vodra, W. (2007) The US FDA in the Drug Development, Evaluation and Approval Process, 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.ch21
Editor Information
- 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
Visiting Professor of Clinical Pharmacology, University of London
Publication History
- Published Online: 25 OCT 2007
- Published Print: 15 DEC 2005
ISBN Information
Print ISBN: 9780727918406
Online ISBN: 9780470987391
- Summary
- Chapter
- References
Keywords:
- food and drug administration;
- drug development;
- new drug application;
- standard operating procedure;
- united states
Summary
This chapter contains sections titled:
Introduction
The Investigational New Drug Application
The new drug application (NDA or BLA)
Conclusions