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New Challenges in Quality Control and Licensure: Regulation

Published online by Cambridge University Press:  14 October 2009

Kenneth R. Brown  and
R. Gordon Douglas Jr
Kenneth R. Brown
Affiliation:
Merck Research Laboratories
R. Gordon Douglas Jr
Affiliation:
Merck Vaccine Division
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Abstract

The Children's Vaccine Initiative (CVI) will result in profound changes in immunization practice. Before the CVI is fully developed, it will present numerous challenges to regulatory practice that will require new applications of existing ideas and innovative solutions to practical issues, especially in combining existing vaccines.

Type
Special Section: Vaccines and Public Health: Assessing Technologies and Public Policies
Information
International Journal of Technology Assessment in Health Care , Volume 10 , Issue 1 , Winter 1994 , pp. 55 - 64
Copyright
Copyright © Cambridge University Press 1994

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References

REFERENCES

1. Acceleration de la recherche concernant l'initiative pour les vaccins de l'enfance. Bulletin de l'Organization Mondiale de la Sante, 1991, 69 (6), 797–803.Google Scholar
2.British Pharmacopoeia, vol. 2. Measles vaccine, live. 1988, 1055–56.Google Scholar
3.Expanded Programme on Immunization: Safety and efficacy of high titre measles vaccine at 6 months of age. Weekly Epidemiological Record, 1991, 66, 249–51.Google Scholar
4. Guidelines for minimizing the risk of transmitting agents causing spongiform encephalop-athy via medical products. Biologicals, 1992, 20, 155–58.CrossRefGoogle Scholar
5.McAleer, W. J., Buynak, E. B., Maigetter, R. Z., et al. Human hepatitis B vaccine from recombinant yeast. Nature, 1984, 307, 178–80.CrossRefGoogle ScholarPubMed
6. Nations cooperate on regulatory standards. FDA Consumer, April 1993, 5.Google Scholar
7.Pittman, M.History of the development of pertussis vaccine. Developments in Biologica Standardization, 1991, 73, 13–29.Google ScholarPubMed
8. Title 21, U.S. Code of Federal Regulations, part 610.11: General safety (revised as of April 1, 1991).Google Scholar
9.World Health Organization. WHO Technical Report Series no. 771. Annex 5: Requirements for measles vaccine live. Geneva, Switzerland: World Health Organization, 1988.Google Scholar
10.World Health Organization. WHO Technical Report Series no. 771. Annex 5: Requirements for measles vaccine live: 6.3 Virus concentration. Geneva, Switzerland: World Health Organization, 1988.Google Scholar
11.World Health Organization. WHO Technical Report Series no. 786. Annex 1: Procedure for evaluating the acceptability in principle of vaccines proposed to United Nations agencies for use in immunization programmes (revised 1988). Geneva, Switzerland: World Health Organization, 1989.Google Scholar
12.World Health Organization. WHO Technical Report Series no. 814. Annex 1: Requirements for Haemophilus type b conjugate vaccines. Geneva, Switzerland: World Health Organization, 1991.Google Scholar