483
Emily A. DiMango, M.D.FDA 483 - Emily A. DiMango, M.D. - August 13, 2024
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Record Details
An FDA inspection of Columbia University Medical Center in New York revealed a significant issue regarding the prompt reporting of serious adverse events. The facility failed to adhere to protocol requirements for timely submission of SAEs to the sponsor. This indicates a lapse in clinical trial oversight and patient safety reporting procedures.
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ID · ea68244e-b31d-4367-b7cc-44dca8a883d2