Table of Contents Author Guidelines Submit a Manuscript
Advances in Preventive Medicine
Volume 2012, Article ID 507571, 11 pages
Review Article

FDA Experience with Medical Countermeasures under the Animal Rule

Global Regulatory Affairs, Quintiles, Inc., 1801 Rockville Pike, Rockville, MD 20852, USA

Received 4 May 2011; Revised 14 July 2011; Accepted 21 July 2011

Academic Editor: Kelly T. McKee

Copyright © 2012 Paul Aebersold. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Linked References

  1. C. Franco, “Billions for biodefense: federal agency biodefense funding, FY2009-FY2010,” Biosecurity and Bioterrorism, vol. 7, no. 3, pp. 291–309, 2009. View at Publisher · View at Google Scholar · View at PubMed
  2. HHS Public Health Emergency Medical Countermeasure Enterprise, “Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats,” April 2007,
  3. J. P. Robinson and J. Goldblat, “Chemical Warfare in The Iran-Iraq War 1980 1988,” SIPRI (Stockholm International Peace Research Institute) Fact Sheet, May 1984,
  4. Resolution 687 of April 1991, United Nations Security Council,
  5. L. A. Cole, The Anthrax Letters: A Medical Detective Story, Joseph Henry Press, 2003.
  6. C. Powell, “Remarks to the United Nations Security Council,”
  7. R. Mowatt-Larssen, “Al Qaeda's Pursuit of Weapons of Mass Destruction,” Foreign Policy, January 2010, View at Google Scholar
  8. Report to the President of the United States, “U.S. Commission on the Intelligence Capabilities of the United States Regarding Weapons of Mass Destruction,” March 2005. View at Google Scholar
  9. R. Rettig, “Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense: Lessons from the Gulf War,” Rand Corporation,
  10. Federal Register, December 1990.
  11. Executive Order 12961, May 1995.
  12. Federal Register, December 1992.
  13. “Administrative documents on FDA website under Drugs@FDA,”
  14. Federal Register, July 1997.
  15. Federal Register, October 1999.
  16. Federal Register, October 1999.
  17. Federal Register, May 2002.
  18. “FDA FY 2012 Budget Request,”
  19. J. Matheny, M. Mair, and B. Smith, “Cost/success projections for US biodefense countermeasure development,” Nature Biotechnology, vol. 26, no. 9, pp. 981–983, 2008. View at Publisher · View at Google Scholar · View at PubMed · View at Scopus
  20. G. Box and R. Draper, Empirical Model-Building and Response Surfaces, Wiley, New York, NY, USA, 1987.
  21. “Administrative documents on FDA website under Drugs@FDA,”
  22. “Administrative documents on FDA website under Drugs@FDA,”
  26. J. E. C. Holty, D. M. Bravata, H. Liu, R. A. Olshen, K. M. McDonald, and D. K. Owens, “Systematic review: a century of inhalational anthrax cases from 1900 to 2005,” Annals of Internal Medicine, vol. 144, no. 4, pp. 270–280, 2006. View at Google Scholar · View at Scopus
  27. “Gulf War Illness and the Health of Gulf War Veterans, Research Advisory Committee on Gulf War Veterans' Illnesses,” November 2008,
  28. “Gulf War and Health: Volume 8: Update of Health Effects of Serving in the Gulf War,” 2010, Institute of Medicine,