Emergent has announced that it has met with the FDA to review regulatory strategy for the development of recombinant anthrax (rPA) vaccine.
Emergent recently submitted rPA Development Plan to FDA, 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.
Daniel Abdun-Nabi, President of Emergent, said: “We are extremely pleased with the feedback that we received from FDA regarding our regulatory strategy for the development of our rPA vaccine candidate.”
“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, he added.