USA – FDA Revamps Adverse Event Reporting Guidance for COVID-19

The US Food and Drug Administration (FDA) on Thursday revised its guidance on postmarket adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing coronavirus disease (COVID-19) pandemic.

The guidance, which applies to drugs, biologics, medical devices, combination products and supplements, details how FDA intends to prioritize adverse event reporting requirements during a pandemic.

The previous version of the guidance from 2012 specifically applied to influenza pandemics. FDA clarifies in the revised guidance that it applies to all pandemics, including COVID-19.

In the guidance, FDA acknowledges that companies and the agency itself may be hit with workforce shortages during a pandemic at the same time as adverse event reporting for products deployed for the pandemic may increase…