Analysis of New Molecular Entity Utilization Patterns using the Sentinel Distributed Database

The FDA’s Sentinel System routinely assesses utilization patterns of new molecular entities (NMEs). These data provide the U.S. Food and Drug Administration (FDA) with information on drug use patterns and sample size availability before inferential studies are initiated using the Active Risk Identification and Analysis (ARIA) System.  

This poster describes users of NMEs approved by the FDA from 2017 to 2021 and characterizes NME utilization patterns. It was presented at the 2024 ISPE Annual Meeting.