Emergent BioSolutions Meets With FDA To Review Regulatory Strategy For Recombinant Anthrax Vaccine

Main Category: Bio-terrorism / Terrorism
Also Included In: Regulatory Affairs / Drug Approvals;  Immune System / Vaccines
Article Date: 14 Jun 2009 - 3:00 PDT

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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. Emergent completed that submission on May 12, 2009 ahead of the June 15, 2009 submission deadline.

"We are extremely pleased with the feedback that we received from FDA regarding our regulatory strategy for the development of our rPA vaccine candidate," stated Daniel Abdun-Nabi, president of Emergent BioSolutions. "This meeting reassured us of the appropriateness of the regulatory strategy that we submitted to FDA and that we can proceed without major modification. As a result of these discussions, Emergent is positioned to advance to the next step in its contract negotiations with HHS for the development and delivery of 25 million doses of an rPA anthrax vaccine to the Strategic National Stockpile."

Source
Emergent BioSolutions Inc.