Antoine E. Azar, M.D. – FDA EIR, Dec 15, 2023

An FDA surveillance inspection of Clinical Investigator Antoine E. Azar, M.D., was conducted from December 12-15, 2023, in Baltimore, MD. The inspection, carried out under regulatory framework CP 7348.811 and 21 CFR regulations for clinical investigators, focused on a breakthrough therapy study supporting a New Drug Application (NDA). This was Dr. Azar's initial inspection, covering a comprehensive review of study conduct, including protocol procedures, source records, investigational drug accountability, and adverse events.

The inspection found no objectionable conditions, and therefore, no FDA Form 483 was issued. However, during the close-out meeting, three minor observations regarding documentation practices were discussed. These included inaccurate times on Electrocardiogram (ECG) printouts without proper justification for corrections, uninitialed corrections or deletions in records, and inconsistencies in updating multiple adverse event logs. Dr. Azar acknowledged these points and committed to addressing them. Planned actions include correcting ECG time settings and developing a Standard Operating Procedure (SOP) for ECG use, drafting a "Best Documenting Practices" course for study coordinators, and exploring methods to improve consistency across adverse event logs. The final classification of the inspection will be determined by the Center for Drug Evaluation and Research.