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Our publications keep professionals working across the public, private, and academic sectors informed on the most important developments and issues in health security and biosecurity.

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Title:

The FDA Animal Efficacy Rule and Biodefense

Authors:
Gigi Kwik Gronvall, Dennis Trent, Luciana Borio, Robert Brey, Lee Nagao, on behalf of the Alliance for Biosecurity
Date posted:
October 01, 2007
Publication type:
Letter
Publication:

Nat Biotechnol 2007;25(10):1084-1087

Publisher:
Nature Publishing Group
DOI:
10.1038/nbt1007-1084
Availability:
Open access
See also:

Letter on publisher's site: PDF

Introduction:

Your editorial in the June issue draws attention to some of the difficulties encountered by companies developing drugs and vaccines under the umbrella of the Bioshield program. We would like to draw attention to one particular impediment to progress—implementation of the US Food and Drug Administration (FDA) Animal Efficacy Rule (‘the Rule’) to facilitate development of medical countermeasures (that is, medicines and vaccines) for bioterrorism.

Letter on publisher's site: PDF

 

 

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