Periodic Safety Update Report (PSUR) Form

1. General Information

Drug Name:
Drug Manufacturer:
Reporting Period:
Submission Date:

2. Safety Summary

Total number of cases reported during the reporting period:
Number of serious cases reported during the reporting period:
Number of non-serious cases reported during the reporting period:
Please provide a safety summary for this period:

3. Line Listing of Serious Adverse Events

Please provide a line listing of serious adverse events for this period:

4. Signal Detection and Evaluation

Number of signals detected during the reporting period:
Please provide information on signal detection and evaluation for this period:

5. Risk Management and Benefit-Risk Evaluation

Number of risks identified during the reporting period:
Please provide information on risk management measures for this period:
Please provide a benefit-risk evaluation for this period:

6. Summary of Regulatory Actions

Please provide a summary of regulatory actions taken during this period:

7. Planned Actions and Recommendations

Please provide a summary of planned actions and recommendations for the next reporting period: