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Duration of Follow Up for New Molecular Entities Approved in 2018: Third Descriptive Analysis

Basic Details
Date Posted
Status
Complete
Medical Product
new molecular entities (NMEs)
Description

In this analysis, we characterized dispensing and administration patterns of 59 New Molecular Entities (NMEs) approved from January 1, 2018, to December 31, 2018, stratified by age and sex in the Sentinel Distributed Database (SDD).

This analysis includes two reports:

  • Report 1: This report characterized dispensing and administration patterns of 26 New Molecular Entities (NMEs) approved from January 1, 2018, to July 31, 2018. The study period includes data from January 1, 2018, to December 31, 2024. We distributed this request to 13 Sentinel Data Partners (DPs) on June 16, 2025.
  • Report 2: This report characterized dispensing and administration patterns of 33 New Molecular Entities (NMEs) approved from August 1, 2018, to December 31, 2018. The study period includes data from January 1, 2018, to December 31, 2024. We distributed this request to 13 Sentinel Data Partners (DPs) on June 23, 2025.
Deliverables (2)
Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2018: Third Descriptive Analysis, Report 1 Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2018: Third Descriptive Analysis, Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2018 - December 31, 2024
Analysis Type
Descriptive
Population / Cohort
All Individuals
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: New Molecular Entities (NMEs) & Utilization Characterization