Which is the chief consumer watchdog which assesses new drugs before they hit the market and continues to monitor safety after they are marketed?

Which is the chief consumer watchdog which assesses new drugs before they hit the market and continues to monitor safety after they are marketed?

• A. Center for Device Evaluation and Research
• B. Center for Drug Evaluation and Research (CDER)
• C. Food and Drug Administration
• D. National Institutes of Health

Answer: (B)

The regulator responsible for both evaluating new drugs before they reach the market and monitoring their safety afterward is the Center for Drug Evaluation and Research. This FDA center reviews clinical trial data to determine if a drug’s benefits outweigh its risks before approval, and it also oversees postmarket safety through ongoing surveillance, adverse event reporting, and labeling or risk-management changes as new safety information emerges. The other options don’t fit as well: the center for device evaluation and research handles medical devices, not drugs; the FDA is the agency, but the question points to the specific center handling drugs; and the National Institutes of Health is a research agency, not a regulatory watchdog.

The regulator responsible for both evaluating new drugs before they reach the market and monitoring their safety afterward is the Center for Drug Evaluation and Research. This FDA center reviews clinical trial data to determine if a drug’s benefits outweigh its risks before approval, and it also oversees postmarket safety through ongoing surveillance, adverse event reporting, and labeling or risk-management changes as new safety information emerges. The other options don’t fit as well: the center for device evaluation and research handles medical devices, not drugs; the FDA is the agency, but the question points to the specific center handling drugs; and the National Institutes of Health is a research agency, not a regulatory watchdog.