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FDA Grants EUA to Freeze-Dried Plasma for DoD Use

Posted 10 July 2018 | By Zachary Brennan 

FDA Grants EUA to Freeze-Dried Plasma for DoD Use

The US Food and Drug Administration (FDA) on Tuesday announced that an emergency use authorization (EUA) has been granted to the US 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.

The move follows the Pentagon’s criticism of FDA’s sluggishness in approving the French freeze-dried plasma product, which some said other countries’ troops have used for years.

Under the EUA, the use of the French product is authorized for the treatment of hemorrhage or coagulopathy of US military personnel “during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical,” FDA said.

The French product is powdered and freeze-dried and can be used following reconstitution in settings where refrigeration is not available.

FDA and the DoD’s Office of Health Affairs in January launched a joint program to prioritize the efficient development of such medical products.

Categories: Regulatory News

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