Definition

The FDA-specific periodic safety report format required for approved drugs, similar to PSUR but with US-specific requirements.

Example

The annual PADER to FDA includes all US adverse experience reports, a narrative discussion of notable cases, and any labeling changes during the period.

Regulatory source

21 CFR 314.80

Common mistakes

Using PSUR format directly without addressing FDA-specific PADER requirements.

Inspector question

How do you handle differences between PSUR/PBRER and PADER requirements?

Related terms