FDA warning letter to Monmouth Medical Center IRB

FDA posted a warning letter to an Institutional Review Board (IRB) this week. Monmouth Medical Center IRB was warned for:

The IRB responded to the FDA 483, but the warning letter notes that the response was unacceptable due to the lack of:

  • The IRB’s subpart D determination for one of the protocols cited in the warning letter
  • A finalized copy of the IRB meeting supplemental form
  • A finalized copy of the IRB checklist used for evaluating pediatric studies
  • Any relevant Standard Operating Procedures (SOPs) that have been revised
  • A projected timeline for the implementation of any new SOPs
  • A description of any training provided to the IRB staff and members on the new SOPs
  • A list of staff and members trained
  • A projected timeline of planned training