Blood & Blood Products

The Center for Biologics Evaluation and Research (CBER) regulates the collection of blood and blood components used for transfusion or for the manufacture of pharmaceuticals derived from blood and blood components, such as clotting factors, and establishes standards for the products themselves. CBER also regulates related products such as cell separation devices, blood collection containers and HIV screening tests that are used to prepare blood products or to ensure the safety of the blood supply.

Most Recent Blood & Blood Products Assessments

Title	Date
COVID-19 Convalescent Plasma Surveillance Protocol	2021/06/15
Blood Components Exposure within the BEST Initiative EHR Network, 2012-2018	2020/08
Trends in Red Blood Cells Transfusions within the Biologics Effectiveness and Safety (BEST) Initiative Network, 2012-2018	2019/10/19
Advancing the Use of the ISBT-128 Coding System in Electronic Health Records to Monitor Blood Transfusion Prevalence in the United States	2018/10/13
Biologics Effectiveness and Safety (BEST) Initiative: Building the Infrastructure for a National Hemovigilance System to Monitor Transfusion-Related Adverse Events	2018/10/13
Biologics Effectiveness and Safety (BEST) Initiative: Incorporating ISBT-128 Codes into OHDSI’s OMOP Common Data Model to Build A National Hemovigilance System to Monitor Transfusion-Related Adverse Events	2018/06/02