FDA Clinical Investigator Warning Letter

FDA posted a warning letter to a Clinical Investigator this week. Dr. Nand was warned for failing to follow the investigational plan, specifically:

  • Enrolling subjects that did not meet inclusion/exclusion (medication doses were not stable)
  • Rescreening laboratory assessments were not taken as required by protocol
  • Exclusionary out of range laboratory values were present at enrollment
  • A subject with hepatitis was enrolled against protocol exclusion criteria

FDA notes that the PI stated that the study monitor verbally confirmed some of the excluded subjects could continue on the study.