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Duration of Follow Up for New Molecular Entities Approved in 2018: Second 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 60 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 is a re-run of a previous analysis, Duration of Follow Up for New Molecular Entities Approved in 2018: First Descriptive Analysis.

This analysis includes two reports:

  • Report 1: This report characterizes the 26 NMEs approved from January 1, 2018 to July 31, 2018. The study period includes data from January 1, 2018 to May 31, 2023. We distributed this request to 13 Sentinel Data Partners on September 8, 2023.
  • Report 2: This report characterizes the 34 NMEs approved from August 1, 2018 to December 31, 2018. The study period includes data from January 1, 2018 to May 31, 2023. We distributed this request to 13 Sentinel Data Partners on September 20, 2023.
Deliverables (2)
Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2018: Second Descriptive Analysis, Report 1 Sentinel Modular Program Report: Duration of Follow Up for New Molecular Entities Approved in 2018: Second Descriptive Analysis, Report 2
Additional Details
FDA Center
CDER
Time Period
January 1, 2018 – May 31, 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