The Food and Drug Administration (FDA) has granted military emergency use authorization of freeze-dried plasma as a means of aiding injury treatment in a potential battlefield setting.
Officials said the action clears the way for Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma to be used for the treatment of hemorrhage or coagulopathy of American military personnel during an emergency involving agents of military combat when plasma is not available for use or when the use of plasma is not practical.
“Earlier this year, we reaffirmed our commitment to the Department of Defense (DoD) and to the dedicated men and women protecting our country, by expediting the development and availability of safe and effective, priority medical products that are essential to the health of our military service members,” FDA Commissioner Scott Gottlieb said. “This is especially true when it comes to products used to treat injuries in a potential battlefield setting. Through our collaborative program with the DoD, they’ve made clear the importance of access to freeze-dried plasma in initial efforts to control hemorrhage from battlefield trauma.”
FDA officials said the agency devotes its highest level of attention in helping expedite the development and review of medical products that are a priority for DoD, to aid in the rapid development and manufacturing of safe and effective medical products for use by American military personnel.