FDA EIR - Daniel J. DeAngelo, MD - April 16, 2021

This FDA Bioresearch Monitoring (BIMO) inspection of Daniel J. DeAngelo, MD, in Boston, MA, occurred from April 12-16, 2021. The inspection, requested by the FDA's Center for Drug Evaluation and Research, reviewed two investigational new drug studies. While no formal Form FDA 483 Inspectional Observations were issued, the inspection identified several concerns. Key issues included a lack of daily dosing data for one study subject due to an unprogrammed device and the failure to return five study drug bottles, both attributed to COVID-19 precautions. Crucially, protocol deviations for these events were not formally reported. Dr. DeAngelo committed to submitting these deviations to the Institutional Review Board and informing the study monitor. Additionally, data listings for Investigator C-Findings in one study had formatting errors, leading to incomplete source records for certain assessments after baseline. The listings also incorrectly omitted subjects with transfusion-independent anemia or thrombocytopenia, contrary to protocol requirements, and lacked listings for hepatomegaly findings, despite data collection. These discrepancies highlight issues with data integrity and adherence to protocol specifications for reporting. The report will be submitted to the FDA center for review and classification.