Duration of Follow Up for New Molecular Entities Approved in 2010, 2012, and 2013

    Basic Details
    Date Posted
    Friday, April 16, 2021
    Status
    Complete
    Medical Product
    new molecular entities (NMEs)
    Description

    In this report we described baseline characteristics and the duration of follow-up time among new users of 20 new molecular entities (NMEs) approved in 2010, 38 NMEs approved in 2012, and 28 NMEs approved in 2013 by the U.S. Food and Drug Administration in the Sentinel Distributed Database (SDD).

    Additional Details
    FDA Center
    CDER
    Time Period
    January 1, 2010 - January 31, 2019; January 1, 2012 - January 31, 2019; January 1, 2013 - January 31, 2019
    Study Type
    Modular Program
    Assessment Type
    Exploratory Analyses
    Population / Cohort
    All individuals
    Data Sources
    Sentinel Distributed Database (SDD)