FDA Releases Guidance on Assessing COVID-19 Symptoms in Clinical Trials

Summary

The US Food and Drug Administration (FDA) has released a final guidance document to help pharmaceutical companies assess COVID-19 symptoms in outpatient adult and adolescent patients participating in clinical trials for COVID-19 prevention or treatment. The guidance provides an example of common symptoms and a method for measuring them, as the agency has determined that public comment is not feasible due to the ongoing public health emergency.