The Food and Drug Administration (FDA) approves vaccines when their benefits outweigh
the risks for their intended use. In this article we review the standard FDA approach to …

Introduction Pharmacovigilance programs protect patient health and safety by identifying
adverse event signals through postmarketing surveillance of claims data and spontaneous …

Introduction Uncovering safety signals through the collection and assessment of individual
case reports remains a core pharmacovigilance activity. Despite the widespread use of …

There is great interest in the application of 'artificial intelligence'(AI) to pharmacovigilance
(PV). Although US FDA is broadly exploring the use of AI for PV, we focus on the application …

Introduction: With increasing availability, the use of healthcare databases as complementary
data source for drug safety signal detection has been explored to circumvent the limitations …

Major vaccine safety controversies have arisen in several countries beginning in the last
decades of 20th century. Such periodic vaccine safety controversies are unlikely to go away …

Monitoring adverse drug events or pharmacovigilance has been promoted by the World
Health Organization to assure the safety of medicines through a timely and reliable …

There are several different proposed data mining methods for the postmarketing
surveillance of drug safety. Adverse events are often classified into a hierarchical structure …

The tree-based scan statistic is a statistical data mining tool that has been used for signal
detection with a self-controlled design in vaccine safety studies. This disproportionality …

Background Previous reports on daptomycin's adverse drug reactions (ADRs) have been
insufficient, often because of limited data. Pharmacovigilance risk signal detection is …