Biologics

FDA Warns 2 Physician Researchers

FDA says two physician researchers at Minneapolis’ Hennepin County Medical Center failed to submit INDs for the conduct of clinical investigations with investigational new drugs. The agency just released a 5/5 Warning Letter to Jon Cole and a 5/6 Warning Letter to Lauren Klein detailing issues with Cole’s studies involving ketamine, haloperidol, and midazolam, and Klein’s studies of olanzapine, haloperidol, ziprasidone, and midazolam.

The inspections were conducted as part of the FDA Bioresearch Monitoring Program, the letters say.

Cole and Klein both claimed that INDs were not needed because the drugs administered in the clinical investigations were not research interventions. Alternatively, they said, if the investigations were subject to FDA jurisdiction, they met all five criteria for an exemption from the requirements of Part 312. The agency rejected both arguments.

FDA Warns 2 Physician Researchers

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