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Talk to a SpecialistTalk to a SpecialistDr. Jon B. Cole, a clinical investigator at Hennepin County Medical Center, failed to obtain required Investigational New Drug (IND) applications before conducting clinical investigations with ketamine and haloperidol/midazolam in two separate protocols for treating severe agitation in pre-hospital settings. The FDA inspection (April 2019) found that Dr. Cole did not comply with 21 CFR 312.20 and 312.40(a), which mandate that a sponsor submit and maintain an active IND before initiating any clinical investigation of drugs subject to FDA jurisdiction, unless a specific exemption applies. This violation was identified as part of the FDA's Bioresearch Monitoring Program, which evaluates whether the rights, safety, and welfare of human subjects are adequately protected during clinical research.