FDA Eases Adverse Event Reporting Requirements During the Pandemic

The FDA announced in a new guidance that it does not plan to object to delays in adverse event reporting for medical products during the pandemic.

Companies that are unable to fulfill normal reporting requirements should document when the pandemic was declared and when it ended, as well as other factors such as a reduced workforce or an increase in adverse event reports that prevent the firms from meeting the normal reporting requirements.

Firms should develop a continuity of operations plan (COOP) that includes instructions for reporting adverse events during a pandemic and should plan to submit any stored reports within six months of the restoration of adverse event reporting processes to their pre-pandemic state, the agency said.

Normal adverse event reporting processes should be maintained to the maximum extent possible, but companies should focus their limited resources on adverse reports related to medical products indicated for the treatment of the disease or prevention of the pathogen causing the pandemic, the agency said.

Read the full guidance here: www.fdanews.com/03-19-20-Guidance.pdf.