Regulatory Affairs Certification (RAC) Practice Exam

If a hypersensitivity reaction occurs that is not listed on your drug label, when should you report it to the FDA?

1. A Within 5 calendar days

2. B Within 10 calendar days

3. C Within 15 calendar days

4. D Within 30 calendar days

The correct answer is: C Within 15 calendar days

The correct response highlights the regulatory requirement regarding the reporting of adverse events, particularly hypersensitivity reactions, that occur during clinical use of a drug. When a hypersensitivity reaction occurs that is not previously specified on the drug label, it is essential to report the event to the FDA within 15 calendar days. This timeframe is stipulated as a standard practice for ensuring prompt communication of significant safety issues to maintain patient safety and regulatory compliance. The reporting window is crucial because it reflects the FDA’s commitment to monitoring drug safety and efficacy. Timely reports can enable the FDA to assess the risk associated with a drug effectively and take necessary actions that may protect public health, such as updating safety information or requiring further investigation. In contrast, other timeframes implied in the options provided, such as 5, 10, or 30 calendar days, do not align with FDA guidance for reporting serious and unexpected adverse reactions. Each option reflects different regulatory requirements that pertain to varying types of alerts and events, but for unexpected hypersensitivity reactions, the specified requirement is indeed within 15 calendar days. This distinction reinforces the importance of adhering to designated timelines for reporting adverse events accurately.