27. Regulatory Issues (FDA and EMA)
- W. John W. Morrow PhD, DSc, FRCPath3,
- Nadeem A. Sheikh PhD4,
- Clint S. Schmidt PhD5,
- D. Huw Davies PhD6
Published Online: 20 JUN 2012
Copyright © 2012 Blackwell Publishing Ltd
Vaccinology: Principles and Practice
How to Cite
Ahmad, M., Byers, V. and Wilson, P. (2012) Regulatory Issues (FDA and EMA), in Vaccinology: Principles and Practice (eds W. J. W. Morrow, N. A. Sheikh, C. S. Schmidt and D. H. Davies), Wiley-Blackwell, Oxford, UK. doi: 10.1002/9781118345313.ch27
Seattle, WA, USA
Dendreon Corporation, Seattle, WA, USA
NovaDigm Therapeutics, Inc., Grand Forks, ND, USA
University of California at Irvine, Irvine, CA, USA
- Published Online: 20 JUN 2012
- Published Print: 3 AUG 2012
Print ISBN: 9781405185745
Online ISBN: 9781118345313
The eradication of diseases such as small pox and reduced threat of infections such as polio have been possible thanks to advances in medical sciences and widespread vaccinations. However, it would be very naïve and complacent for us to think that there will not be another disease such as AIDS or SARS sooner or later.
Preparing populations for health threats from either new or re-emerging infectious diseases is recognized as an important public health priority.
Vaccines offer a cost-effective means to prevent disease, including cancer. However, there are regulatory issues associated with each vaccine that is developed and the aim of this chapter is to discuss the regulatory issues faced by vaccines from both the FDA and EMEA.