Difference between PADER and PBRER
Periodic Benefit-Risk Evaluation Report (PBRER),
U.S. periodic adverse drug experience report (PADER)
U.S. periodic adverse experience report (PAER),
ICH E2C Periodic Safety Update Report (PSUR)
See attached PDF file for details.
| Feature | PADER | PSUR/PBRER |
| Scope | Specific to the United States | Used worldwide |
| Primary Objective | Detailed individual case reports | Comprehensive benefit-risk evaluation |
| Regulatory Authority | US FDA | Various global regulatory bodies |
| Guidelines | US 21 CFR 314.80 | ICH E2C R2, EMA Module VII |
| Content Complexity | Simpler (about 5 sections) | More detailed (about 20 sections) |
| Key Content | Serious unlisted event cases – Regulatory updates | Regulatory updates – Cumulative and interval exposure – Clinical trials overview – Signal overview – Benefit-risk assessment |
| Frequency | Quarterly for first 3 years, then annually | Every six months for first 2 years, then annually |
| Submission Timeline | Quarterly: within 30 days of DLP. Annual: within 60 days of DLP. | Six-monthly: within 70 days of DLP Annual/Multiyear: within 90 days of DLP |
| Product Coverage | Separate PADER for each NDA, with some exceptions | One PSUR/PBRER for different forms or uses of a product |
Reference:
https://www.fda.gov/media/85520/download
E2C(R2) Periodic Benefit-Risk Evaluation Report (PBRER) Guidance for Industry