HHS Extends Deadline For Bidders In Competitive Range For Recombinant Anthrax Vaccine Contract To Submit Development Plan To FDA For Review

Main Category: Immune System / Vaccines
Also Included In: Regulatory Affairs / Drug Approvals;  Bio-terrorism / Terrorism
Article Date: 24 Apr 2009 - 2:00 PDT

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Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Department of Health and Human Services (HHS) issued an additional amendment to its request for proposal for an Anthrax Recombinant Protective Antigen (rPA) Vaccine for the Strategic National Stockpile.

This new amendment, which follows an amendment previously issued on April 15, 2009 requesting that all bidders submit a comprehensive plan outlining the regulatory strategy to FDA for review, extends the deadline for submission of such a plan to June 15. This new amendment applies to all bidders in competitive range for the rPA contract. The original amendment required submissions within 15 days of April 15th, the date the amendment was first issued.

Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions, stated, "We are confident in our submission package that we had been planning to submit in satisfaction of the original deadline. With that said, we fully support HHS's decision to grant additional time to submit a development plan package for FDA review."

Source
Emergent BioSolutions Inc