IND Safety Report Deadlines (21 CFR 312.32)
IND safety report deadlines under 21 CFR 312.32.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Who is reporting
- Sponsor or sponsor-investigator
- Unexpected fatal or life-threatening suspected adverse reaction
- Yes
- Date the sponsor determined it qualifies
- 2026-10-05
- Date the sponsor first received the information
- 2026-10-01
Result: 7-day notification due no later than October 8, 2026.
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Who is reporting
- Unexpected fatal or life-threatening suspected adverse reaction (sponsor)
- Date the sponsor determined it qualifies (YYYY-MM-DD)
- Date the sponsor first received the information (YYYY-MM-DD)
- Date of an FDA request for more data (YYYY-MM-DD, optional)
How this is calculated
Citation
21 CFR 312.32(c) and (d): IND safety reports within 15 calendar days of the sponsor determining the information qualifies, and 7 calendar days from first receipt for an unexpected fatal or life-threatening suspected adverse reaction. 21 CFR 312.64(b) for investigators. Read the sources: 21 CFR 312.32 ↗, 21 CFR 312.64 ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.