FDA 483 - Emily A. DiMango, M.D. - August 13, 2024

An FDA inspection conducted at Emily A. DiMango, M.D., located at Columbia University Medical Center, from August 5 to August 13, 2024, resulted in a Form FDA 483 observation. The inspection focused on the Principal Investigator's conduct of a clinical trial. The primary violation identified was the failure to promptly report a serious adverse event (SAE) to the study sponsor, directly contravening the established clinical protocol. Specifically, Protocol (b)(4), Section 13.1.2.2, mandates reporting all SAEs within a defined period. An example cited involved a subject's worsening condition and hospitalization, which was documented at a Week 16 visit but reported to the sponsor on July 26, 2022, exceeding the required promptness. This observation, issued pursuant to Section 704(b) of the Federal Food, Drug, and Cosmetic Act, indicates practices that may demonstrate non-compliance with regulations governing clinical investigations. The firm is expected to implement immediate corrective actions to address this observation, ensuring timely and accurate reporting of all serious adverse events in accordance with study protocols and regulatory requirements, thereby upholding patient safety and data integrity in clinical trials.