483
Edward C. Hsiao, M.D., Ph.D.FDA 483 - Edward C. Hsiao, M.D., Ph.D. - June 29, 2021
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Record Details
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.
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ID · 5f28dc69-32b9-4ad0-86d0-81c456af9f41