FDA Issues Revised Guidance on Adverse Event Reporting During a Pandemic

In response to rapidly changing conditions due to the COVID-19 pandemic, the US Food and Drug Administration (“FDA”) published a revised guidance on postmarket adverse event reporting requirements. The revised guidance applies to drugs, biologics, medical devices, combination products and dietary supplements.

The revised guidance addresses the following areas:

Information on Pandemic Preparedness: The guidance directs manufacturers to the Department of Health and Human Services Pandemic Preparedness Resources website for frequently updated information on the pandemic.

Development of a Continuity of Operations Plan in the Case of a Pandemic: The guidance notes that general information on pandemic preparedness planning can