News: FDA updates COVID-19 guidance to address adverse events
The U.S. Food and Drug Administration (FDA) has updated its guidance on the clinical trials amidst the pandemic to address how and when the sponsors and application holders should report serious adverse events (SAE). The updates come days after FDA's newly introduced Q&A to the documents concerning alternate laboratory or imaging centers, video conferencing, and postmarketing studies.
The updated guidance answers two questions on the SAE addressing different requirements for different circumstances. While the first question addresses situations where a company studying an already approved drug under an investigational new drug application (IND) receives a spontaneous report of a serious adverse event, the second question addresses how sponsors studying drugs for non-COVID-19 indications should handle reporting serious adverse events associated with COVID-19 during the trial.