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Duration of Follow Up for New Molecular Entities Approved in 2022: First Descriptive Analysis

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

    In this report, we characterized dispensing and administration patterns of 37 New Molecular Entities (NMEs) approved from January 1, 2022 through December 31, 2022, stratified by age and sex in the Sentinel Distributed Database (SDD).

    We distributed this request to five Sentinel Data Partners on November 14, 2024. The study period included data from January 1, 2022 to most recent available data (May 31, 2024). The date of the most recent available data differs across Data Partners; hence, for this request we limited distribution to those Data Partners that had data available for at least one year from December 31, 2022. This allowed for a minimum of one complete year of data to study utilization patterns for all NMEs. Please see Appendix A for a list of dates of available data for each Data Partner.

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2022 - May 31, 2024
    Analysis Type
    Descriptive
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)
    Workgroup Leader(s)

    Terrence Lee