FDA 483 - Myung-Ju Ahn, M.D., Ph.D. - January 26, 2024
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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.
ID · 1e7b76a4-e5ea-4408-b9ca-e8435c5194e6