USA – FDA guidance targets adverse event reporting during trials

The US Food and Drug Administration (FDA) last week updated its guidance on conducting clinical trials amid the coronavirus disease (COVID-19) pandemic to address how and when sponsors and application holders should report serious adverse events (SAE).
 
The latest update to the guidance comes just days after FDA added new questions and answers to the document addressing the use of alternate laboratory or imaging centers, video conferencing and postmarketing studies. (RELATED: FDA updates guidance on clinical trials amid COVID-19Regulatory Focus 13 May 2020).
 
Serious adverse events
 
The updated guidance includes two new questions and answers on serious adverse event reporting requirements in different circumstances.
 
The first question addresses situations where a company studying an already approved drug to treat COVID-19 under an investigational new drug application (IND) receives a spontaneous report of a serious adverse event stemming from the product’s off-label use in clinical practice to treat COVID-19…