The U.S. Food and Drug Administration (FDA) announced that an emergency use authorization (EUA) had been granted to the DOD on July 9, 2018, enabling the emergency use of French-manufactured Freeze-Dried Plasma for treatment of hemorrhage or coagulopathy involving agents of military combat (e.g., firearms, projectiles, and explosive devices). At this time, this EUA only applies to the use of the French-manufactured plasma, which significantly limits the amount of product available to the Armed Services Blood Program.

The volume of product available and the requirement for training and regulatory compliance under the EUA for use of the product greatly restrict our current ability to field this product across the DOD, allowing only limited distribution of the product as a force health protection investigational product. However, ongoing efforts to develop an American-manufactured freeze-dried plasma product continue, with an estimated time-frame of FDA approval in FY25. Once the American-manufactured product becomes FDA approved, it will provide the DOD with a greater capacity to field a needed blood product.

For more information on this FFDP EUA and related documents:

• See the FFDP section of the FDA EUA website
• Read the FDA news release granting emergency-use authorization