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Duration of Follow Up for New Molecular Entities Approved in 2020: 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 53 New Molecular Entities (NMEs) approved from January 1, 2020 to December 31, 2020, stratified by age and sex in the Sentinel Distributed Database (SDD).

    This analysis includes three reports:

    • Report 1: This report characterizes the 16 NMEs approved from January 1, 2020 to April 30, 2020. The study period includes data from January 1, 2020 to August 31, 2022. We distributed this request to 14 Sentinel Data Partners on February 15, 2023.
    • Report 2: This report characterizes the 22 NMEs approved from May 1, 2020 to August 31, 2020. The study period includes data from January 1, 2020 to December 31, 2022. We distributed this request to 13 Sentinel Data Partners on April 14, 2023.
    • Report 3: This report characterizes the 15 NMEs approved from September 1, 2020 to December 31, 2020. The study period includes data from January 1, 2020 to December 31, 2022. We distributed this request to 12 Sentinel Data Partners on May 11, 2023.
    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2020 – August 31, 2022; January 1, 2020 – December 31, 2022
    Analysis Type
    Descriptive
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)