Manufacturers are ____ to report adverse events to the oversight agency.

• A. Required
• B. Permitted
• C. Optional
• D. Discouraged

Answer: (A)

Manufacturers are required to report adverse events to the oversight agency. This obligation is a cornerstone of pharmacovigilance and post‑market safety monitoring. By making reporting mandatory, regulators gather comprehensive safety information, detect new risks, and act quickly to protect public health. Reporting isn’t optional, permissible, or discouraged; those terms would imply there’s no binding duty or even a push against reporting, which would weaken the system that tracks drug and device safety. When the obligation to report is met consistently, surveillance signals can be identified sooner and appropriate regulatory actions can be taken to reduce harm.