FDA issues EUA for freeze-dried plasma product to support American military personnel

EUA updates

FDA issues EUA for freeze-dried plasma product to support American military personnel

July 9, 2018: FDA issued (PDF, 208 KB) an Emergency Use Authorization (EUA) to the U.S. Department of Defense (DoD) to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma (referred to as French FDP) manufactured by the Centre de Transfusion Sanguine des Armées.  Under the EUA, this product is authorized for the treatment of U.S. military personnel with severe or life-threatening hemorrhage due to traumatic injuries sustained in the conduct of military operations in situations when plasma is not available for use or when its use is not practical.  Related links: News release: FDA takes action to support American military personnel by granting an authorization for freeze-dried plasma product to enable broader access while the agency works toward approval of the product (July 10, 2018)  French FDP EUA information, including fact sheets and instructions for use