- File number:
- FDA-2020-D-1824
- Issued by:
-
Guidance Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
The Food and Drug Administration (FDA or agency) announces the availability of final guidance for industry titled “Assessing COVID-19-Related Symptoms in Adult and Adolescent Ambulatory Subjects in Clinical Trials of Drugs and Biologics for the prevention or treatment of COVID-19. .” Although the state of 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 a problem of public health persisting with continued prevention and treatment efforts. The FDA is issuing this guidance to provide sponsors and investigators with thoughts on approaches to how common symptoms related to COVID-19 can be measured and analyzed in clinical trials evaluating drugs or biologics for prevention or treatment of COVID-19 in outpatient adults and adolescents. topics. This directive replaces the directive of the same name published on September 29, 2020.
Submit comments
You may submit comments online or in writing on any guidance at any time (see 21 CFR 10.115(g)(5))
If you are unable to submit comments online, please send your written comments to:
Records Management
Food and Drug Administration
5630 Fishers Lane, room 1061
Rockville, Maryland 20852
All written comments must be identified by the file number of this document: FDA-2020-D-1824.
