FDA Postmarketing Adverse Event Report Deadlines (21 CFR 314.80, 600.80, 310.305)
The FDA postmarketing adverse event report that applies, and its due date.
Open the tool → Runs in your browser. Data leaves only if you deliberately send a problem report from the interactive tool.
Example
- Setting
- Approved drug, NDA or ANDA (21 CFR 314.80)
- Most serious outcome
- Inpatient hospitalization or prolongation of one
- Unexpected (not listed in the current labeling); needed when serious
- Yes
- Date the information was first received
- 2026-10-01
Result: 15-day Alert report due no later than October 16, 2026.
The tool opens with these values already filled in. Replace them with your own.
What you enter
- Setting
- Most serious outcome
- Unexpected (not listed in the current labeling); needed when serious
- Date the information was first received (YYYY-MM-DD)
- Postmarketing study (optional)
- Approval or license date, for periodic reports (YYYY-MM-DD)
How this is calculated
Citation
21 CFR 314.80(c), 600.80(c) and 310.305(c): postmarketing 15-day Alert reports for serious and unexpected adverse experiences, and periodic reports (quarterly for 3 years, then annual). Read on eCFR as current October 8, 2026. Read the sources: 21 CFR 314.80 ↗, 21 CFR 600.80 ↗, 21 CFR 310.305 ↗
A reference and educational tool. Not medical, legal, or financial advice, and not a substitute for clinician judgment.