top of page
- Annual Safety Report (ASR)
In clinical trials, an annual report of all newly available safety information. An ASR includes a global analysis for all trials with the same Investigational Medicinal Product (IMP).
Development Safety Update Report (DSUR)
Annual review and evaluation by the sponsor of safety information collected during the reporting period related to a drug, biologic or vaccine under development, whether it is marketed.
Periodic Safety Update Report (PSUR)
Also called PBRER (Periodic Benefit Risk Evaluation Report). This report (internationally agreed format) provides a periodic comprehensive evaluation of the risk-benefit balance, efficacy and effectiveness data of a marketed drug or biological product. It contains a summary of relevant data, a scientific evaluation, and data concerning sales volume, prescription, and population exposure.
Periodic adverse drug experience report (PADER)
A post-marketing safety report submitted to the United States Food and Drug Administration (USFDA). The main objective is to provide summary data and an assessment of an approved drug product’s benefit risk profile from the post marketing exposure.
bottom of page