FDA EIR - Brian E. Driver, MD, Sponsor/Investigator - April 22, 2016

An FDA inspection was conducted on Brian E. Driver, M.D., Sponsor-Clinical Investigator, from April 18-22, 2016, at Hennepin County Medical Center, as a high-priority compliance follow-up. Guided by FDA Compliance Programs 7348.810 and 7348.811, this second inspection focused on Dr. Driver's oversight of human subject research.

The inspection resulted in a four-item FDA 483, identifying significant and repeat violations. Primary issues included the repeated failure to submit an Investigational New Drug (IND) application for an ongoing clinical investigation, a requirement under 21 CFR 312. Dr. Driver also failed to ensure proper study monitoring and did not conduct investigations according to approved plans. Specific breaches included enrolling subjects who met exclusion criteria (e.g., potentially pregnant women), not reporting serious adverse events, failing to obtain post-treatment informed consent (a repeat observation), improper subject randomization, and incorrect drug dosing. Furthermore, accurate case histories were not maintained, with inconsistent adverse event classification and data entry errors.

Discussions addressed the need for improved documentation, delegation of authority, training, and tracking of deviations and adverse events. Dr. Driver committed to implementing corrections, though he initially disagreed on the IND requirement for one study. The FDA stressed adherence to protocols, subject safety, and robust data integrity practices.