Which FDA center oversees the regulation of biologic products?

• A. Center for Drug Evaluation and Research
• B. Center for Devices and Radiological Health
• C. National Center for Toxicological Research
• D. Center for Biologics Evaluation and Research

Answer: (D)

Biologics are regulated by the FDA’s Center for Biologics Evaluation and Research. This center specializes in products like vaccines, blood and blood components, cellular and gene therapies, and other biologics produced from living organisms. It reviews how these products are made, ensures safety and efficacy, and approves them through the Biologics License Application pathway, which is distinct from the traditional NDA route used for many conventional drugs. The other centers have different mandates: the Center for Drug Evaluation and Research handles conventional drugs; the Center for Devices and Radiological Health oversees medical devices; and the National Center for Toxicological Research is primarily a research unit that supports regulatory decisions rather than directly regulating products.