Authorization of Emergency Use of a Freeze-Dried Plasma Product for Treatment of Hemorrhage or Coagulopathy During an Emergency Involving Agents of Military Combat; Availability

Samenvatting

The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use of a freeze-dried plasma product, octaplasLG Powder, for emergent treatment of hemorrhage or coagulopathy 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.