FDA EIR - Eunice Wang, M.D. - June 05, 2018

An FDA inspection was conducted at the clinical investigator site of Eunice Wang, M.D., located at Roswell Park Cancer Institute in Buffalo, NY, from May 31 to June 5, 2018. This inspection, the first for Dr. Wang, was performed at the request of the Center for Drug Evaluation and Research, Office of Scientific Investigations, following Compliance Program 7348.811 for Clinical Investigators and Sponsor-Investigators. Its purpose was to evaluate adherence to regulatory requirements for Protocol STML-401-0114, an ongoing study supporting Biologics License Application (BLA) 761116 for the drug Tagraxofusp (SL-401). The inspection thoroughly reviewed critical aspects of the clinical trial, including subject eligibility, informed consent processes, Institutional Review Board (IRB) approvals, study monitoring, adverse event reporting, concomitant medications, case report forms, protocol deviations, disease response data, study drug accountability, and staff training. The review covered 27 screened subjects and 13 enrolled subjects. Significantly, the inspection revealed no data integrity issues, under-reporting of adverse events, or any other protocol deviations beyond those already documented and reported. At the conclusion of the inspection, no Form FDA 483, Inspectional Observations, was issued, indicating an absence of objectionable conditions. Consequently, no specific regulatory actions were required from the clinical investigator.