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Nuclear/Biological/Chemical (NBC) Defense - Federation of ...

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• Awarded a manufacturing development contract.<br />

• NDA is under preparation.<br />

Product: Multichambered Autoinjector<br />

Joint Medical <strong>NBC</strong> <strong>Defense</strong> Research Programs<br />

Concept:<br />

• Speed administration <strong>of</strong> life-saving antidotes against nerve agents.<br />

• Replace two-Injector Mark I Nerve Agent Antidote Kit with single autoinjector.<br />

Status:<br />

• Engineering contract awarded in September 1993.<br />

• Fielding will require full FDA approval.<br />

• Demonstrated the human safety <strong>of</strong> the multi-chambered autoinjector.<br />

• Engineering and development <strong>of</strong> final prototype completed.<br />

Product: Cyanide Pretreatment<br />

Concept:<br />

• Provide protection against incapacitation and lethality without performance degradation.<br />

• Enhance soldier protection and sustainment.<br />

Status:<br />

• Completed preclinical toxicology and drug distribution studies.<br />

• Developed dose parameters and performance assessments.<br />

• Concluded animal toxicology studies for cyanide pretreatment.<br />

• Completed preparation <strong>of</strong> IND application.<br />

• Initial efforts to conduct first human safety tests.<br />

• Draft Engineering and Manufacturing Development Request for Proposals undergoing<br />

staffing.<br />

D-9

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