FDA EIR - David Miklos, MD - July 27, 2017

An FDA Establishment Inspection Report details a high-priority PDUFA User Fee inspection of clinical investigator David Miklos, MD, located in Palo Alto, CA. The inspection took place from July 24-27, 2017, under Compliance Program 7348.811, focusing on study protocol KTE-C19-101 (ZUMA-1) for refractory aggressive Non-Hodgkin Lymphoma. The review encompassed inclusion/exclusion criteria, investigational product accountability, and comprehensive subject record analysis. Importantly, no FDA-483 Inspectional Observations were issued during this inspection, signifying a largely compliant operation. However, a key discussion point at the close-out centered on reported protocol deviations regarding the timing of baseline PET-CT scans, which were performed outside the specified timeframe before chemotherapy conditioning. Dr. Miklos acknowledged this observation and committed to preventing its recurrence. A prior inspection in April 2017 was similarly classified as "No Action Indicated," with a minor discussion about subjects signing outdated informed consent forms. The clinical investigator was reminded of their responsibility to comply with the Federal Food, Drug, and Cosmetic Act, with potential consequences for non-compliance including regulatory meetings, warning letters, injunctions, debarment, and civil or criminal penalties.