483
William A. Gahl, MD, PhDWilliam A. Gahl, MD, PhD – FDA 483, Dec 19, 2024
Record Details
An FDA inspection of NIH / NIH Clinical Center in Bethesda, MD, identified one observation related to their role as a Sponsor-Investigator. The firm failed to monitor the progress of an investigation conducted under an IND, specifically lacking documentation of clinical monitoring throughout the study. This indicates a deficiency in oversight of clinical trial activities.
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ID · 9551cbe4-974c-4f9b-8b60-a18836efe15c
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