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Duration of Follow Up for New Molecular Entities Approved in 2019: 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 48 New Molecular Entities (NMEs) approved from January 1, 2019 to December 31, 2019, 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 2019: First Descriptive Analysis.

    This analysis includes two reports:

    • Report 1: This report characterizes the 26 NMEs approved from January 1, 2019 to August 31, 2019. The study period includes data from January 1, 2019 to May 31, 2023. We distributed this request to 13 Sentinel Data Partners on July 25, 2023.
    • Report 2: This report characterizes the 22 NMEs approved from September 1, 2019 to December 31, 2019. The study period includes data from January 1, 2019 to May 31, 2023. We distributed this request to 13 Sentinel Data Partners on September 18, 2023.
    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2019 – May 31, 2023
    Analysis Type
    Descriptive
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)