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
Today, the U.S Food and Drug Administration announced that an emergency use authorization (EUA) has been granted to the U.S. Department of Defense (DoD) to enable the emergency use of Pathogen-Reduced Leukocyte-Depleted Freeze-Dried Plasma manufactured by the Centre de Transfusion Sanguine des Armées (referred to in the EUA as French FDP).
“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. This is especially true when it comes to products used to treat injuries in a potential battlefield setting,” said FDA Commissioner Scott Gottlieb, M.D. “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. Granting this authorization will support access to this important product in the event it’s needed. The FDA remains deeply committed to implementing an enduring pathway to ensure that these potentially life-saving medical products are made available in the most expeditious, safe and effective manner possible.”
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