FDA 483 - Myung-Ju Ahn, M.D., Ph.D. - January 26, 2024

An FDA inspection of Myung-Ju Ahn, M.D., Ph.D. in Seoul, Korea, revealed significant deviations from Good Clinical Practices during a Phase 2 study for small cell lung cancer. Observations included the enrollment of subjects who did not meet eligibility criteria and a widespread failure to report non-serious adverse events to the sponsor according to the study protocol timetable. These findings indicate serious concerns regarding data integrity and patient safety in the clinical trial.