The FDA said today it granted an emergency use authorization to the US Department of Defense for the use of particular freeze-dried plasma products designed for the treatment of hemorrhage or coagulopathy.
The approval specifically covers the use of pathogen-reduced leukocyte-depleted freeze-dried plasma produced by the Centre de Transfusion Sanguine des Armées, known in the EU as French FDP, according to an FDA release.
The freeze-dried plasma product is now cleared for use in treating US military personnel during emergencies where plasma is not available for use or when the use of plasma is not practical, the federal watchdog said. The agency added that hemorrhage, sometimes accompanied by coagulopathy, are the leading cause of preventable deaths among combat trauma casualties.
The EUA was issued in response to request from the DoD, the FDA said, after receiving the required determination by the DoD and a declaration by the Secretary of the Department of Health and Human Services, and is the result of a collaborative deal between the FDA and DoD.
“Earlier this year, we reaffirmed our commitment to the Department of Defense 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. 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,” FDA Commissioner Dr. Scott Gottlieb said in a prepared statement.
In January, both the FDA and the Pentagon announced the launch of a joint program to speed the development of medical products for military personnel.
The federal safety watchdog and the Defense Dept.’s Office of Health Affairs said the program’s framework is based on a House bill passed last year that expands the FDA’s authority to approve the emergency use of unapproved medical treatments and aims to expedite the approval process.
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