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FDA Issues Final Order - AVA Safe and Effective, Protects Individuals at High Risk for Anthrax Disease
- POLICIES
- Continuation of the Anthrax Vaccine Immunization Program (AVIP)
22 Dec 05
On 15 Dec 05, the FDA issued a Final Rule & Order on the license status of anthrax vaccine adsorbed (AVA). After reviewing extensive scientific evidence and carefully considering comments from the public, the FDA again determined that AVA is licensed for the prevention of anthrax, regardless of the route of exposure.
In response to the FDA's action, policy options for AVIP are now under review. Unless otherwise directed by the Secretary or Deputy Secretary of Defense, the services are directed to continue implementation of the AVIP as authorized in April 2005. This interim approach will protect the same personnel, and include an option to refuse and periodic reporting requirements.
- SERVICE MESSAGES
- PLANNING DOCUMENTS
- DoD AVIP Implementation Instructions 30 Mar 07
[DOC]
[PDF]
Includes
compliance assurance documents
- QUESTIONS & ANSWERS
- NEWS
- DoD Statement
The Food and Drug Administration (FDA) issued a Final
Order reaffirming previous conclusions that the anthrax vaccine prevents
anthrax resulting from any route of exposure, including inhalation anthrax.
- FOOD AND DRUG ADMINISTRATION (FDA)
- On 15 December 2005, The Food and Drug Administration (FDA) released a
Final Order with respect to anthrax vaccine adsorbed (AVA), to be published
in the Federal Register on 19 December 2005.
- After review of the comments and finding no additional scientific
evidence to alter the proposed categorization, FDA accepts the previous
Panel抯 recommendation and adopts Category I as the final category for AVA
and determines AVA to be safe and effective and not misbranded.
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View the FDA Final Order
AVIP EUA expired 14 Jan 06 The following content is provided for archival purposes
- POLICIES
- SERVICE MESSAGES
- FOOD AND DRUG ADMINISTRATION (FDA)
- EUA REQUEST AND AUTHORIZATION
- FEDERAL REGISTER
- [Docket No. 2005N�40] [2 Feb 05]
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; Availability
- US DISTRICT COURT MEMORANDUM OPINION & ORDER
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John Doe #1, et al, Plaintiffs, v. Donald H. Rumsfeld, et al, Defendants (Order)
United States District Court for the District of Columbia
Judge Emmet G. Sullivan
6 Apr 05
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John Doe #1, et al, Plaintiffs, v. Donald H. Rumsfeld, et al, Defendants (Order & Opinion)
United States District Court for the District of Columbia
Judge Emmet G. Sullivan
27 Oct 04
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