What Is a PADER? Understanding the Periodic Adverse Drug Experience Report
Pharmacovigilance plays a critical role in ensuring patient safety throughout a product’s lifecycle. One of the key regulatory requirements in the United States is the Periodic Adverse Drug Experience Report (PADER). This report allows regulatory authorities to continuously evaluate the safety profile of approved and marketed medicinal products.
A Periodic Adverse Drug Experience Report (PADER) is a pharmacovigilance document submitted to the U.S. Food and Drug Administration (FDA) by marketing authorization holders. It provides a cumulative summary and analysis of adverse drug experiences associated with a medicinal product during a defined reporting period.
Periodic Adverse Drug Experience Reports help the FDA identify emerging safety signals and assess whether regulatory action is necessary to protect public health.
When Is a PADER Required?
PADER submission timelines depend on the product’s approval status:- Quarterly reports during the first three years after FDA approval
- Annual reports thereafter
Reports must be submitted within 30 days of the data lock point, in compliance with 21 CFR 314.80 and 21 CFR 600.80.
Key Components of a PADER
Adverse Event Summary Includes both domestic and foreign serious and non-serious adverse events reported during the interval. Signal Evaluation A critical analysis of new or increased safety signals and trends. Literature Review Summary of relevant published safety information. Regulatory Actions Updates on labeling changes, risk mitigation measures, or ongoing commitments.Importance of PADER Compliance
Accurate and timely Periodic Adverse Drug Experience Report submissions ensure continued regulatory compliance, support benefit–risk evaluation, and help prevent enforcement actions.
How Masuu Global Supports PADER Reporting
Masuu Global provides end-to-end pharmacovigilance services, including Periodic Adverse Drug Experience Report preparation, medical review, quality checks, and FDA submissions, ensuring reliable compliance and patient safety.