PADER: The Periodic Adverse Drug Experience Report, Explained
A Periodic Adverse Drug Experience Report is the routine postmarket safety report an application holder submits to FDA for an approved drug. It is required by 21 CFR 314.80, and it is the US-specific member of a family of periodic safety reports that otherwise look quite different from each other.
Its job is narrow and worth stating plainly. The PADER is not an analysis of whether your drug is still safe. It is a periodic accounting of the adverse experiences you received, in a prescribed format, so FDA can see what you saw.
What is in one
The report covers the interval since the last one and contains:
- A narrative summary and analysis of the adverse drug experience information in the period, and an analysis of the 15-day Alert Reports submitted during it.
- FDA Form 3500A reports for serious, unexpected experiences not already submitted as 15-day Alerts, and for non-serious or expected ones.
- A history of actions taken since the last report because of adverse drug experiences, for example labelling changes or studies initiated.
- An index of the reports included.
The 15-day Alert Report is the separate, faster obligation: a serious and unexpected adverse experience is reported within 15 calendar days of receipt, not held for the periodic report. The PADER accounts for those alerts; it does not replace them.
When it is due
Quarterly for the first three years after approval, then annually. Quarterly reports are due within 30 days of the close of the quarter, annual reports within 60 days of the anniversary date of approval.
The clock runs from approval, not from launch, which catches sponsors whose commercial launch trailed approval by a year.
PADER and PBRER are not the same report
This causes real confusion because both are "the periodic safety report" in different rooms.
| PADER | PBRER (ICH E2C(R2)) | |
|---|---|---|
| Where | US, 21 CFR 314.80 | ICH regions, including the EU as the PSUR |
| Orientation | A listing and accounting of received reports | A benefit-risk evaluation |
| Content | Form 3500A reports, narrative summary, actions taken | Cumulative safety analysis, signal evaluation, benefit-risk conclusion |
| Question it answers | What did you receive | What does it mean |
FDA will accept a PBRER in place of a PADER if you request and obtain a waiver under 314.90. Companies marketing in multiple regions usually do exactly that, because writing one PBRER is cheaper than writing a PBRER and a PADER, and the PBRER is the more informative document.
If you are only in the US and only ever will be, the PADER is the lighter obligation and there is no reason to volunteer for the other one.
Where PADERs go wrong
- Missing the waiver opportunity. Multi-region sponsors writing both reports in parallel, when a 314.90 waiver would have let one document serve.
- Treating it as a formality. The narrative summary and the analysis of 15-day Alerts are substantive, and a summary that says nothing is a finding waiting to happen.
- Counting from launch. The reporting clock starts at approval.
- Inconsistency with the alerts already filed. The PADER accounts for the 15-day Alerts submitted in the period. When the accounting does not match what was actually filed, the discrepancy is visible to FDA and invisible to you.
- Actions taken left out. A labelling change made because of adverse experience information belongs in the history of actions, and its absence reads as a gap in your own record-keeping.
Frequently asked questions
What is a PADER?
A Periodic Adverse Drug Experience Report, the routine postmarket safety report required for approved drugs under 21 CFR 314.80. It accounts for the adverse experiences received during the reporting interval.
How often is a PADER due?
Quarterly for the first three years after approval, then annually. Quarterly reports are due 30 days after the close of the quarter, annual reports 60 days after the anniversary of approval.
What is the difference between a PADER and a PBRER?
A PADER is a US listing and accounting of received reports. A PBRER, defined by ICH E2C(R2), is a benefit-risk evaluation. FDA may waive the PADER in favour of a PBRER on request under 21 CFR 314.90.
Does a PADER replace 15-day Alert Reports?
No. Serious and unexpected adverse experiences are reported within 15 calendar days of receipt. The PADER accounts for those alerts and covers the rest.
When does the reporting clock start?
At approval, not at commercial launch. Sponsors whose launch trailed approval by a year are often surprised to find reports were already due.
What form are individual case reports submitted on?
FDA Form 3500A, the MedWatch form for mandatory reporting by manufacturers, distributors and importers.