Jeffrey W. Taub, M.D./Children's Hospital of Michigan – FDA Warning Letter, Oct 12, 2022

The FDA issued a Warning Letter to Dr. Taub following an inspection from September 23 to October 12, 2022, regarding clinical investigations for (b)(4). The inspection, part of the Bioresearch Monitoring Program, identified two significant violations of 21 CFR Part 312.

First, Dr. Taub failed to ensure the investigation adhered to the investigational plan (21 CFR 312.60). Specifically, pediatric Subject (b)(6) in Protocol (b)(4) continued to receive (b)(4) treatment through Week 61, beyond the protocol-specified Week 49 for low-risk subjects. This resulted in three additional doses of (b)(4) and three additional five-day cycles of (b)(4), exposing the subject to increased risks of neurologic and hematologic toxicity. Dr. Taub's response, attributing the error to subinvestigator misinterpretation and noting IRB notification, was deemed inadequate due to insufficient detail on corrective and preventive actions, particularly regarding policies and procedures to ensure protocol compliance.

Second, Dr. Taub failed to ensure continuous IRB review and approval (21 CFR 312.66). IRB approval for Protocol (b)(4) lapsed from January 14 to January 24, 2022, during which study activities, including subject visits and drug administration, continued. While Dr. Taub cited