Postmarketing Reporting of Adverse Drug Experiences
The US regulation requiring applicants to report postmarketing adverse drug experiences to the FDA — serious and unexpected reports as expedited 15-day "Alert Reports", plus periodic safety reporting — feeding the FDA Adverse Event Reporting System (FAERS).
Holders of approved NDAs/ANDAs for marketed drugs. Parallel biologics reporting sits under 21 CFR 600.80.
How a marketed drug’s postmarketing adverse experiences reach the FDA.
| Report | Covers | Deadline |
|---|---|---|
| 15-day “Alert Report” | Adverse experiences that are both serious AND unexpected (foreign or domestic) | 15 calendar days from receipt |
| Periodic (PADER) | All other reports — non-serious, or expected | Quarterly for 3 years after approval, then annually |
The applicant must investigate all reports and submit follow-up within 15 calendar days; each quarterly report is due within 30 days of the close of the quarter. Reports feed the FDA Adverse Event Reporting System (FAERS).
Source: 21 CFR 314.80(c). Verify against the current text before relying on it for a submission.
- 01Submit serious, unexpected ADEs as 15-day expedited reports
- 02Submit periodic safety reports on the required schedule
- 03Conduct and document diligent case follow-up
Aligned over time with electronic ICSR submission to FAERS using the ICH E2B(R3) standard.
21 CFR 314.80: frequently asked questions
Quick answers to common questions about 21 CFR 314.80.
What is 21 CFR 314.80?
21 CFR 314.80 — Postmarketing Reporting of Adverse Drug Experiences — is a regulation issued by the Food and Drug Administration (United States). The US regulation requiring applicants to report postmarketing adverse drug experiences to the FDA — serious and unexpected reports as expedited 15-day "Alert Reports", plus periodic safety reporting — feeding the FDA Adverse Event Reporting System (FAERS).
Who does 21 CFR 314.80 apply to?
Holders of approved NDAs/ANDAs for marketed drugs. Parallel biologics reporting sits under 21 CFR 600.80.
What are the key requirements of 21 CFR 314.80?
FDA 21 CFR 314.80 requires, among other things: Submit serious, unexpected ADEs as 15-day expedited reports; Submit periodic safety reports on the required schedule; Conduct and document diligent case follow-up.
When was 21 CFR 314.80 last updated?
The current version of 21 CFR 314.80 dates from January 2023. Aligned over time with electronic ICSR submission to FAERS using the ICH E2B(R3) standard.
Track the standards that move
When 21 CFR 314.80 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.