Which center within the FDA is primarily responsible for regulating biologics?

• A. Office for Regulatory Affairs (ORA)
• B. Center for Biologics Evaluation and Research (CBER)
• C. Center for Drug Evaluation and Research (CDER)
• D. Center for Veterinary Medicine (CVM)

Answer: (B)

Biologics require specialized evaluation of complex manufacturing processes and clinical data, so the FDA assigns this work to its Center for Biologics Evaluation and Research. This center is specifically focused on human biologics like vaccines, blood-derived products, cellular and gene therapies, and monoclonal antibodies, as well as biosimilars, which need unique regulatory scrutiny beyond traditional small-molecule drugs. Other centers handle different areas: traditional drugs are overseen by the Center for Drug Evaluation and Research, veterinary products by the Center for Veterinary Medicine, and the Office of Regulatory Affairs deals with inspections and enforcement rather than primary product regulation. So, the center responsible for regulating biologics is the Center for Biologics Evaluation and Research.