FDA 483 - Edward C. Hsiao, M.D., Ph.D. - June 29, 2021

Edward C. Hsiao, M.D., Ph.D., a clinical investigator in San Francisco, CA, was inspected by the FDA. The inspection revealed a significant issue with the timely reporting of serious adverse events (SAEs) to the Institutional Review Board (IRB) for two clinical studies. This indicates a failure to adhere to the investigational plan and proper oversight of patient safety reporting.