FDA components affecting medication use: Which center regulates prescription and nonprescription drugs?

FDA components affecting medication use: Which center regulates prescription and nonprescription drugs?

• A. Center for Biologics Evaluation and Research (CBER)
• B. Center for Drug Evaluation and Research (CDER)
• C. Center for Devices and Radiologic Health (CDRH)
• D. Center for Veterinary Medicine (CVM)

Answer: (B)

Focus on how the FDA divides responsibilities among its centers. For human medicines—whether prescribed or sold over the counter—the regulating body is the Center for Drug Evaluation and Research. This center reviews new drug applications, approves drugs for use, sets labeling and safety standards, and monitors post-market safety for all human medicines, including both Rx and OTC products. Other centers have different missions: biologics (like vaccines and some complex therapies) fall under the Center for Biologics Evaluation and Research; medical devices are overseen by the Center for Devices and Radiologic Health; and veterinary medicines are handled by the Center for Veterinary Medicine. So, prescription and nonprescription human drugs are the domain of CDER.

Focus on how the FDA divides responsibilities among its centers. For human medicines—whether prescribed or sold over the counter—the regulating body is the Center for Drug Evaluation and Research. This center reviews new drug applications, approves drugs for use, sets labeling and safety standards, and monitors post-market safety for all human medicines, including both Rx and OTC products. Other centers have different missions: biologics (like vaccines and some complex therapies) fall under the Center for Biologics Evaluation and Research; medical devices are overseen by the Center for Devices and Radiologic Health; and veterinary medicines are handled by the Center for Veterinary Medicine. So, prescription and nonprescription human drugs are the domain of CDER.