Edward C. Hsiao, M.D., Ph.D. – FDA EIR, Jun 29, 2021

An FDA inspection of Edward C. Hsiao, M.D., Ph.D., a Clinical Investigator at the University of California, San Francisco, was conducted from June 10 to June 29, 2021. This high-priority BIMO inspection, under Compliance Program 7348.811, evaluated studies regulated by the Federal Food, Drug, and Cosmetic Act.

The main violation, cited on a Form FDA 483, involved the late reporting of Serious Adverse Events (SAEs) to the Institutional Review Board (IRB). Specifically, 7 out of 17 SAEs for one study and 1 out of 3 for another were submitted beyond the required UCSF IRB policy timeframe.

Additional issues discussed included other instances of late SAE submissions to the sponsor/CRO, two subjects undergoing consent prior to official site activation, the omission of a Sub-Investigator from the Form FDA 1572, and a two-week lapse in IRB continuing review approval for a study.

Dr. Hsiao committed to corrective actions, including implementing an SAE tracking spreadsheet, providing refresher training for staff, ensuring weekend coverage for SAE reporting, and establishing backup reporting procedures. Further actions include ensuring comprehensive listing of all study team members on regulatory documents and submitting IRB renewal applications earlier to prevent approval lapses.