ROCKVILLE, Md. — Emergent BioSolutions Inc. announced April 22, 2009, that the U.S. Department of Health and Human Services 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 extends the deadline to June 15 to submit a comprehensive plan outlining the regulatory strategy to the Food and Drug Administration for review. This new amendment applies to all bidders in competition for the rPA contract.
“We are confident in our submission package that we had been planning to submit in satisfaction of the original deadline,” said Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions. “With that said, we fully support HHS’ decision to grant additional time to submit a development plan package for FDA review.”