Center Articles and Publications

The FDA Animal Efficacy Rule and Biodefense
Gigi Kwik Gronvall, Dennis Trent, Luciana Borio, Robert Brey, and Lee Nagao on behalf of the Alliance for Biosecurity

Nature Biotechnology. 2007;25:1084-1087. © Nature Publishing Group – partner of AGORA, HINARI, CrossRef and COUNTER. All rights reserved. doi:10.1038/nbt1007-1084

Introduction: To the editor—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.

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