The U.S. Army is seeking information on current good manufacturing processes for a cryopreserved platelets product to aid the Army Medical Materiel Development Activity’s endeavors to treat severe hemorrhage caused by combat trauma.
USAMMDA seeks to develop medical products through collaborations with commercial partners in efforts to protect military combatants as part of the U.S. Combat Casualty Care Research Program, the service branch said in a FedBizOpps notice posted Tuesday.
The agency noted that it has already conducted Phase 1 and Phase 2 of CPP-related clinical studies and trials under an investigational new drug application.
The request for information aims to identify a commercial partner and regulatory sponsor to support USAMMDA through Phase 3 post-marketing studies and eventually secure a Food and Drug Administration license for the CPP product.
USAMMDA will accept responses to the RFI through Oct. 20.