Availability of Medical Countermeasures for Bioterrorism Events: US Legal and Regulatory Options

Clinical Pharmacology and Therapeutics

Volumn 85, Issue 6, 2009, Pages 669-671

  Maher, C ^a   Lushniak, B D ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL WARFARE; EMERGENCY CARE; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE ACCESS; HEALTH CARE AVAILABILITY; HEALTH CARE POLICY; HEALTH PROGRAM; LAW ENFORCEMENT; PRIORITY JOURNAL; SHORT SURVEY; UNITED STATES;

BIOTERRORISM; DISASTER PLANNING; DRUG APPROVAL; EMERGENCIES; HEALTH SERVICES ACCESSIBILITY; HUMANS; LIABILITY, LEGAL; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 67349144699     PISSN: 00099236     EISSN: 15326535     Source Type: Journal    
DOI: 10.1038/clpt.2009.55     Document Type: Short Survey

References (19)

1. Graham, B. et al. World at Risk: The Report of the Commission on the Prevention of WMD Proliferation and Terrorism (Vintage Books, New York, 1993).
2. Mackby, J. Strategic Study on Bioterrorism (Center for Strategic and International Studies, Washington, DC, 2006). Accessed 28 October 2008.
3. IOM (Institute of Medicine). Dispensing Medical Countermeasures for Public Health Emergencies: Workshop Summary (The National Academies Press, Washington, DC, 2008).
4. Trust for America's Health (TFAH). Ready or not? Protecting the public's health from diseases, disasters, and bioterrorism 2008. Robert Wood Johnson Foundation, Princeton, NJ, 2008.
5. Project Bioshield Act of 2004, Public Law 108-276, 42 U.S.C. 243 et seq.
6. Pandemic and All-Hazards Preparedness Act, Public Law 109-417, 42 U.S.C. 300hh-11 et seq.
7. Public Readiness and Emergency Preparedness Act, Public Law 109-148, 42 U.S.C. 247d-6d.
8. Public Health Security and Bioterrorism Preparedness and Response Act of 2002, Public Law 107-188, 42 U.S.C. 201 et seq.
9. Bush, G.W. National Security Presidential Directive 17/Homeland Security Presidential Directive 4 unclassifed version: National Strategy to Combat Weapons of Mass Destruction, Washington, DC, 2002.
10. Bush, G.W. Homeland Security Presidential Directive 10: Biodefense for the 21st Century, Washington, DC, 2002.
11. Bush, G.W. Homeland Security Presidential Directive 18: Medical Countermeasures Against Weapons of Mass Destruction, Washington, DC, 2007.
12. Bush, G.W. Homeland Security Presidential Directive 21: Public Health and Medical Preparedness, Washington, DC, 2007.
13. Public Health Service Act, as amended, 42 U.S.C. Chapter 6A.
14. Federal Food Drug and Cosmetic Act, as amended, 21 U.S.C. 301 et seq. See also, Federal Food, Drug, and Cosmetic Act. Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy and Commerce: Food, Drug, and Related Law, As Amended Through December 31, 2004 [prepared for the use of the Committee on Energy and Commerce, US House of Representatives], March 2005. .
15. US Food and Drug Administration. 21 Code of Federal Regulations 312.36.
16. US Food and Drug Administration. 21 Code of Federal Regulations 312.34.
17. US Food and Drug Administration. 21 Code of Federal Regulations 814.3(n).
18. US Food and Drug Administration. Guidance: Emergency Use Authorization of Medical Products. (July 2007).
19. US Food and Drug Administration. FDA Emergency Use Authorization Letter. (24 February 2009).