Biologics License Applications
Overview
Biological license applications are submitted to the Food and Drug Administration by blood establishments prior to using automated blood collection devices to collect red blood cells, platelets and plasma. These applications request FDA approval and licensure for the facilities to collect the products either individually or in combination, as described in standard operating procedures. If a licensed blood establishment begins using a new or different automated collection device, it is required to submit a supplement to its biological license to the FDA.
To aid blood establishments in meeting the requirements for submitting a biologics license application or a license supplement, the Coalition for Blood Safety — composed of AABB, America’s Blood Centers, the American Red Cross and the Armed Services Blood Program — formed a task force charged with creating checklists that provide establishments with details on the information and materials required for biological license application or licensure supplement submissions involving platelet, red blood cells and fresh frozen plasma collected by apheresis.