FDA EIR - Marina Konopleva, M.D. - May 18, 2018

An FDA inspection of Clinical Investigator Marina Konopleva, M.D., located in Houston, TX, was conducted from May 15 to May 18, 2018. This comprehensive inspection, Dr. Konopleva's first, was initiated under the FY 2018 BIMO Inspection Request from the Center for Drug Evaluation and Research (CDER) and followed regulatory framework CP 7348.811 for Clinical Investigators. The focus was on the study "SL-401 in Patients with Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm" (Protocol STML-401-0114), sponsored by Stemline Therapeutics, Inc. The inspection revealed no significant findings, and importantly, no FDA Form 483 was issued. Review of twenty-six subject source documents, regulatory binders, informed consent forms, device accountability, monitoring records, adverse event reporting, and other critical study documentation showed no deficiencies. Primary efficacy endpoint data was also verified without discrepancies. The only item noted for discussion was the absence of a 'Corrective Action Plan' for certain line items on the Protocol Deviation Tracking Form. Therefore, the required action is to ensure all protocol deviations are accompanied by a complete corrective action plan on the tracking form to maintain comprehensive documentation of study conduct.