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Emergent BioSolutions Inc.
Emergent BioSolutions Meets With FDA To Review Regulatory Strategy for Recombinant Anthrax Vaccine
June 29th, 2009
Emergent BioSolutions Inc. (NYSE:EBS) announced that it has met with the U.S. Food and Drug Administration (FDA) to review Emergent's regulatory strategy for the development of its recombinant anthrax (rPA) vaccine. Emergent recently submitted to FDA, among other documents, its rPA Development Plan in response to the Department of Health and Human Services' (HHS) amendment to its request for proposal (RFP) to develop and deliver up to 25 million doses of an rPA vaccine for the Strategic National Stockpile. In amending the RFP, HHS required that all bidders deemed to be in the competitive range submit to FDA a comprehensive plan outlining the regulatory strategy for their rPA vaccine....
Source: Biotech Business Week (2009-06-29)
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