Biologics license applications are submitted to the Food and Drug Administration by blood establishments prior to distributing blood and blood components in interstate commerce. Effective October 2011, the same requirements will apply to certain unrelated cord blood products. 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. Supplements to approved BLAs are required to be submitted to FDA when changes are made to the facility's manufacturing processes.
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 biologics license application or licensure supplement submissions involving platelets, red blood cells and fresh frozen plasma collected by apheresis.
AABB also works directly with government agencies, including the FDA, by submitting comments and providing reviews of regulatory issues concerning the requirements of the BLA and IND application process.
FDA announced a draft guidance for industry titled "Changes to an Approved Application: Biological Products — Human Blood and Blood Components Intended for Transfusion or for Further Manufacture." The guidance is issued to manufacturers of licensed whole blood and blood components intended for transfusion or further manufacture as well as source plasma. It provides recommendations to assist with determining the most appropriate reporting mechanism through which changes may be submitted to an approved biologics license application. The document also addresses applicability and content of comparability protocols as well as labeling changes. Once the guidance has been finalized, it will replace the document of the same title dated July 2001
FDA issues a guidance on the BLA process related to minimally manipulated, unrelated, allogeneic placental/umbilical cord blood and compliance with applicable regulatory requirements.
FDA issues a draft guidance on investigational new drug applications for HPC-Cs, providing recommendations for use that is not licensed but needed for treatment of a patient with a serious or life-threatening disease or condition.