Emergency Expanded Access Follow-Up Deadlines (21 CFR 312.310, 56.104)
Follow-up deadlines after an emergency expanded access use of an investigational drug.
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Example
- Date FDA authorized the emergency use
- 2026-11-20
- Date of the emergency use at the institution
- 2026-11-23
Result: Expanded access submission to FDA: December 14, 2026. Report to the IRB: December 1, 2026.
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What you enter
- Date FDA authorized the emergency use (YYYY-MM-DD)
- Date of the emergency use at the institution (YYYY-MM-DD)
How this is calculated
Citation
21 CFR 312.310(d)(2): an expanded access submission within 15 working days of FDA authorizing an emergency use. 21 CFR 56.104(c): the emergency use reported to the IRB within 5 working days. 21 CFR 312.310(c)(2): a written summary at the conclusion of treatment. Read the sources: 21 CFR 312.310 ↗, 21 CFR 56.104 ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.