Posts Tagged ‘Periodic Adverse Drug Experience Report’

Young Pharmacist With A Tablet In Drug Store

Painless PADERs From Argus Safety Without Wonky Counts

Periodic Adverse Drug Experience Report (PADER) is a part of post-marketing cumulative safety reports that need to be submitted to the United States Food and Drug Administration (US FDA). It provides a brief summary of changing post-approval AE profiles and safety information of an approved drug along with the benefit-risk profile evaluation. The Oracle Argus […]