The US FDA has 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 the FDA added new questions and answers to the document addressing the use of alternate laboratory or imaging centers, video conferencing and postmarketing studies. The updated guidance includes two new questions and answers on serious adverse event reporting requirements in different circumstances. Learn More