Back to: FDA Regulatory Education for Industry (REdI) 2024 Conference – Biologics Track
Presenter
Orieji Illoh, MD
Director
Division of Blood Components and Devices (DBCD)
Office of Blood Review and Regulation (OBRR)
Center for Biologics Evaluation and Research (CBER)
US Food and Drug Administration (FDA)
Dr Illoh joined FDA in 2009. Currently, she serves as the Director, Division of Blood Components and Devices in the Office of Blood Research and Review. She oversees regulatory activities related to blood and blood components for transfusion, plasma for fractionation, blood collection containers and storage solutions, devices used in the manufacture of blood and blood components, plasma volume expanders and oxygen carrying solutions. Prior to joining the FDA, Dr Illoh practiced Clinical Pathology and Transfusion Medicine at the University of Virginia, Charlottesville, and then at the University of Texas Medical School in Houston.
Abstract
The Office of Blood Research and Review (OBRR) regulates blood and blood components for transfusion and for further manufacturing into derivatives like albumin and IVIG. This office oversees the regulatory review of blood products, devices used in their manufacture, and related drugs, ensuring safety, purity, and potency. OBRR also engages in mission-related research, develops policy and guidance documents, issues safety communications, and conducts inspections and compliance activities at blood establishments. Blood is uniquely regulated as both a biologic under the Public Health Service (PHS) Act, requiring licensure for interstate commerce, and a drug under the Federal Food, Drug, and Cosmetic (FD&C) Act, subject to current good manufacturing practice (GMP) regulations. A critical focus of these regulations is ensuring both product safety for patients and donor safety. The licensure process for blood establishments involves submitting a Biologic License Application (BLA), which includes detailed information on manufacturing processes (SOPs), quality control data, and labeling. OBRR staff review these applications and conduct pre-license and pre-approval inspections to verify compliance with regulations before granting licenses or approving changes. Inspection findings directly impact regulatory decisions. The work of OBRR is essential for maintaining a safe and available blood supply for public health needs.