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Duration of Follow Up for New Molecular Entities Approved in 2021: Second 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 50 New Molecular Entities (NMEs) approved from January 1, 2021, to December 31, 2021, stratified by age and sex in the Sentinel Distributed Database (SDD).

This analysis is a re-run of a previous analysis, Duration of Follow Up for New Molecular Entities Approved in 2021: First Descriptive Analysis.

This analysis includes two reports:

  • Report 1: This report characterizes the 27 NMEs approved from January 1, 2021, to June 30, 2021. The study period included data from January 1, 2021, to April 30, 2025. We distributed this request to 13 Sentinel Data Partners on September 3, 2025.
  • Report 2: This report characterizes the 23 NMEs approved from July 1, 2021, to December 31, 2021. The study period included data from January 1, 2021, to April 30, 2025. We distributed this request to 13 Sentinel Data Partners on September 3, 2025.
Deliverables (2)
Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2021: Second Descriptive Analysis, Report 1 Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2021: Second Descriptive Analysis, Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2021 - April 30, 2025
Analysis Type
Descriptive
Population / Cohort
All individuals
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Analysis: Duration of Follow Up for New Molecular Entities Approved in 2021: First Descriptive Analysis
Sentinel Drug Study: New Molecular Entities (NMEs) & Utilization Characterization