FDA Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator today. Dr. Gabriel was warned for:

  • Failing to follow the investigational plan, specifically:
    • Randomizing twenty five (25) subjects prior to receipt of protocol required laboratory values (serum creatinine)
    • Overdosing two subjects as a result of not having the serum creatinine values and estimated glomerular filtration rates (eGFRs) at randomization
    • Failure to down-titrate the dose of study drug based on eGFR as required by the protocol for one subject