Pediatric Utilization of New Molecular Entities (NMEs): A Summary of Early Post-Marketing Uptake in the Sentinel Distributed Database

A wide range of  New Molecular Entities (NMEs) are approved by the US Food and Drug Administration (FDA) each year. Many of these products have no information regarding appropriate use in the pediatric population at the time of approval. Currently there is a gap in our understanding of early post-marketing utilization of newly approved NMEs in pediatric patients.

This poster characterizes the uptake of NMEs approved from 2017 to 2021 among users 0-17 years of age in the Sentinel Distributed Database (SDD). It was presented at the 2024 ISPE Annual Meeting.