483
Steven M. Wolf, M.D.Steven M. Wolf, M.D. – FDA 483, Mar 5, 2026
Record Details
An FDA inspection of Steven M. Wolf, M.D. in Hawthorne, NY, identified a significant issue related to clinical trial conduct. The firm, acting as a sponsor-investigator, failed to submit a protocol amendment to the Institutional Review Board and the FDA regarding changes in the maximum dose of an investigational drug. This indicates a lapse in regulatory compliance concerning the oversight and reporting of study modifications.
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