FAEMS reports can be filed by which parties?

• A. Regulators; Manufacturers
• B. Healthcare Professionals; Public
• C. Patients; Researchers
• D. Hospitals Only

Answer: (B)

The main concept is that FAERS (the FDA Adverse Event Reporting System) is built to collect adverse event reports from a broad range of observers to monitor drug safety. It relies on spontaneous reports from both healthcare professionals and members of the public, so it can capture detailed medical information from clinicians and real-world experiences from patients and other consumers.

Healthcare professionals provide clinically rich information about the event, the patient’s condition, and relevant medical history. The public—patients and other consumers—can file reports to share their experiential data, which may reveal safety signals that professionals alone might miss. Together, these two groups form the essential sources of FAERS data, helping regulators identify and assess potential risks.

The other options aren’t correct because regulators’re not the primary reporters into FAERS, and hospitals aren’t restricted to that role nor the sole reporters. Researchers may study safety data, but they aren’t the standard direct reporters in FAERS in the way clinicians and the public are.