Emergency Use Authorization (EUA) to enable use of needed products in civilian and military emergencies, United States

Emerging Infectious Diseases

Volumn 13, Issue 7, 2007, Pages 1046-1051

  Nightingale, Stuart L ^a,b   Prasher, Joanna M ^a   Simonson, Stewart ^a,c  

^a U S DEPARTMENT OF HEALTH AND HUMAN SERVICES   (United States)

^b NATIONAL INSTITUTES OF HEALTH   (United States)

^c Center for Global Health Convergence   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRAX VACCINE;

ARMY; AUTHORITY; EMERGENCY HEALTH SERVICE; EMERGENCY USE AUTHORIZATION; FOOD AND DRUG ADMINISTRATION; GOVERNMENT; HEALTH CARE POLICY; HEALTH PROGRAM; HOSPITAL MANAGEMENT; HUMAN; MEDICAL PRACTICE; PHYSICIAN; PREVENTIVE HEALTH SERVICE; PUBLIC HEALTH; PUBLIC HEALTH SERVICE; REVIEW; UNITED STATES;

EID: 34447292867     PISSN: 10806040     EISSN: 10806059     Source Type: Journal    
DOI: 10.3201/eid1307.061188     Document Type: Review

References (13)

1. Draft guidance. Emergency use authorization of medical products; availability. [cited 2006 Sep 30]. Available from http://www.fda.gov/oc/ bioterrorism/emergency_use.html
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3. Young FE, Norris JA, Levitt JA, Nightingale SL. The FDA's new procedures for use of investigational drugs in treatment. JAMA. 1988;259:2267-70.
4. Young FE, Nightingale SL. Information on treatment INDs as they become available to the practitioner. JAMA. 1988;260:247.
5. Dupont RL, Dormer RA, Nightingale SL. The treatment of narcotics addiction with narcotic drugs. JAMA. 1976;235:1565-6.
6. 5 Federal Register 52814-52817. Dec 21, 1990.
7. Howe EG, Martin ED. Treating the troops. Hastings Center report. March-April 1991.
8. 64 Federal Register 54179- 4189. Oct 5, 1999.
9. 10 USC 1107(f). Notice of use of an investigational new drug or a drug unapproved for its applied use.
10. Project BioShield Act of 2004 (Public Law 108-276).
11. 72 Federal Register 4710-4711.
12. Declaration of Emergency pursuant to 21 USC §360bbb-3(b). [cited 2007 Feb 8]. Available from http://www.fda.gov/cber/vaccine/anthraxeua.htm
13. Authorization of emergency use of Anthrax Vaccine Adsorbed for prevention of inhalation anthrax by individuals at heightened risk of exposure due to attack with anthrax. [cited 2007 Feb 8]. Available from http://www.fda.gov/cber/ vaccine/anthraxeua.htm