IND Safety Reports

FDA Requirements

Mandatory Safety Report Requirements

  • Initial report: Any suspected adverse reaction that is both serious and unexpected must be reported to FDA within 15 calendar days of the Sponsor-Investigator's initial receipt of the information.
  • Follow-up report: Any relevant additional information related to a previously submitted IND safety report must be submitted without delay, no later than 15 calendar days after the Sponsor-Investigator receives the information.

Submitting IND Safety Reports

All IND safety reports must be submitted: 
The submission must be identified as:
  • IND safety report” for 15-day reports, or
  • 7-day IND safety report” for unexpected fatal or life-threatening suspected adverse reaction reports, or
  • Follow-up IND safety report” for follow-up information.
The report must be submitted to an appropriate FDA Review division that has the responsibility to review the IND application under which the safety report is submitted.

FDA recommends that sponsors submit safety reports electronically  Other means of rapid communication to the respective review division’s Regulatory Project Manager (e.g., telephone, facsimile transmission, email) may also be used.