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Duration of Follow Up for New Molecular Entities Approved in 2017: Third 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, 2017 to December 31, 2017, stratified by age and sex in the Sentinel Distributed Database (SDD).

    This analysis is a re-run of two previous analyses, Duration of Follow Up for New Molecular Entities Approved in 2017: First Descriptive Analysis and Duration of Follow Up for New Molecular Entities Approved in 2017: Second Descriptive Analysis.

    This analysis includes two reports:

    • Report 1: This report characterizes the 23 NMEs approved from January 1, 2017 to June 30, 2017. The study period includes data from January 1, 2017 to November 30, 2022. We distributed this request to 14 Sentinel Data Partners on March 22, 2023.
    • Report 2: This report characterizes the 25 NMEs approved from July 1, 2017 to December 31, 2017. The study period includes data from January 1, 2017 to December 31, 2022. We distributed this request to 14 Sentinel Data Partners on May 4, 2023.
    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2017 – November 30, 2022; January 1, 2017 – December 31, 2022
    Analysis Type
    Descriptive
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)