Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment; Guidance for Industry; Availability

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The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment." Although the public health emergency declared by the Department of Health and Human Services under section 319 of the Public Health Services Act has ended, COVID-19 remains an ongoing public health problem with continued prevention and treatment efforts. FDA is issuing this guidance to provide sponsors and investigators with considerations for approaches on how common COVID- 19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adult and adolescent subjects. This guidance supersedes the guidance of the same name issued on September 29, 2020.