Which FDA center is responsible for regulating prescription and nonprescription drugs?

• A. Center for Biologics Evaluation and Research (CBER)
• B. Center for Devices and Radiological Health (CDRH)
• C. Center for Drug Evaluation and Research (CDER)
• D. Office of the Commissioner

Answer: (C)

The main concept is identifying which FDA center regulates drugs used by patients, whether prescribed or sold over the counter. The Center for Drug Evaluation and Research handles this scope, evaluating the safety and efficacy of new drug substances, approving prescription medications, and overseeing over-the-counter drug status as well as the generic drug pathway. It also ensures manufacturing quality and post-market safety. The other centers focus on different product areas: biologics like vaccines and blood products are regulated by the Center for Biologics Evaluation and Research; medical devices by the Center for Devices and Radiological Health; and the FDA Office of the Commissioner provides overarching leadership and policy rather than drug-specific regulation. So the center responsible for prescription and nonprescription drugs is the Center for Drug Evaluation and Research.