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.

The PADER is a periodic accounting of the adverse experiences you received, in a prescribed format, so FDA can see what you saw. It does not evaluate whether the drug is still safe.

Contents

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 labeling 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.

Due dates

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 versus PBRER

FDA will accept a PBRER in place of a PADER if you request and obtain a waiver under 314.90. Multi-region sponsors usually do, 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.

Common PADER failures

• 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 an empty summary invites an inspection finding.
• 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, FDA can see the discrepancy.
• Actions taken left out. A labeling 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.