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Non-Insulin Antidiabetics & Duration of Follow-Up and Duration of Use

    Basic Details
    Status
    Complete
    Last Updated
    Tuesday, April 2, 2019
    Health Outcome(s)
    duration of follow-up
    duration of use
    Purpose
    Methods and Development
    Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
    No
    Regulatory Determination / Use

    Feasibility assessment that supported an ARIA sufficiency determination to replace a sponsor postmarketing requirement (PMR) safety study for canagliflozin and renal cell carcinoma.