FDA Waives Some Adverse Event Reporting Deadlines Amid COVID-19

In light of the COVID-19 pandemic, FDA says it will not take enforcement action against certain companies that do not submit adverse event reports to the agency within the standard required timeframe. FDA is taking the action to reduce burden on medical product manufacturers, which may experience staffing reductions while also seeing increased adverse event reports during the pandemic, the agency said in a revised final guidance issued Friday (March 20). Though FDA is taking a more lax approach to...