FDA EIR - Hagop M. Kantarjian, M.D. - March 16, 2018

The FDA conducted an inspection of Dr. Hagop M. Kantarjian, M.D., a clinical investigator at the University of Texas MD Anderson Cancer Center, from March 12-16, 2018. This assessment, initiated by the CDER Office of Scientific Investigations, focused on evaluating the investigator's conduct and records for protocol AG120-C-001, a Phase 1 study of investigational drug AG-120 for advanced hematologic malignancies. The inspection was conducted in accordance with compliance policy 7348.811 for Clinical Investigators and relevant Good Clinical Practice (GCP) regulations.

Unlike a previous inspection in 2017, which identified issues with consent form dating and adverse event reporting, the current inspection did not result in an FDA Form 483 (Inspectional Observations). However, discussions addressed one instance of a late Serious Adverse Event (SAE) report and minor protocol deviations such as out-of-window patient visits, missing laboratory specimens, incomplete assessments, and absent questionnaires. No formal regulatory actions were mandated by the FDA; site management indicated that the late SAE reporting issue would be addressed internally.