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Food and Drug Administration / Pharmacology / Pharmaceutical industry / Medical informatics / Clinical research / Structured Product Labeling / Package insert / MedWatch / Clinical trial / Pharmaceutical sciences / Medicine / Health


Raxibacumab (Raxibacumab)
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Document Date: 2012-12-27 10:55:55

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File Size: 315,93 KB

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Reference / /

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United States / /

IndustryTerm

worstcase manufacturing conditions / clinical protocol / manufacturing deviations / drug product / supplemental applications / biological product / manufacturing facilities / manufacturing / drug products / clinical protocols / licensed biological products / /

MedicalCondition

anthrax / /

MedicalTreatment

clinical protocols / clinical protocol / /

Organization

Food and Drug Administration Center for Drug Evaluation and Research Central Document Room / Research Division of Compliance Risk / FDA / Food and Drug Administration Center for Drug Evaluation / Research office of Prescription Drug Promotions / Research ENCLOSURE / MPH Director Office / Antimicrobial Products Center for Drug Evaluation / Research Division of Compliance Risk Management and Surveillance / /

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EDWARD M COX / Edward Cox / Jane A. Dean / /

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Position

Regulatory Health Project Manager / regulatory project manager / Regulatory Project Manager for this application / /

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Maryland / /

Technology

pharmacokinetics / clinical protocol / drug development / pdf / /

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http /

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