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Duration of Follow Up for New Molecular Entities Approved in 2021: First Descriptive Analysis

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

In this analysis, we characterize dispensing and administration patterns of 51 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 includes two reports:

  • Report 1: This report characterizes the 28 NMEs approved from January 1, 2021 to June 30, 2021. The study period includes data from January 1, 2021 to May 31, 2023. We distributed this request to 12 Sentinel Data Partners on September 21, 2023.
  • Report 2: This report characterizes the 23 NMEs approved from July 1, 2021 to December 31, 2021. The study period includes data from January 1, 2021 to June 30, 2023. We distributed this request to 13 Sentinel Data Partners on November 20, 2023.
Deliverables (2)
Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2021: First Descriptive Analysis, Report 1 Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2021: First Descriptive Analysis, Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2021 – May 31, 2023; January 1, 2021 – June 30, 2023
Analysis Type
Descriptive
Population / Cohort
All individuals
Data Sources
Sentinel Distributed Database (SDD)
Related Links
Sentinel Drug Study: New Molecular Entities (NMEs) & Utilization Characterization