IND Effective Date, Annual Report and New-Investigator Notice (21 CFR 312)
When an IND goes into effect and when its annual reports are due.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Date FDA received the IND
- 2025-03-01
Result: IND in effect March 31, 2025
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Date FDA received the IND (YYYY-MM-DD)
- Earlier date FDA said the study may begin (YYYY-MM-DD, optional)
- Date a new investigator was added (YYYY-MM-DD, optional)
How this is calculated
Citation
21 CFR 312.40(b): an IND goes into effect 30 days after FDA receives it, or on earlier notification. 21 CFR 312.33: an annual report within 60 days of the anniversary of that date. 21 CFR 312.30(c): notice of a new investigator within 30 days. Read the sources: 21 CFR 312.40 ↗, 21 CFR 312.33 ↗, 21 CFR 312.30 ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.