Regulatory Open Forum

 View Only
Reg Intel Conference 2024
Back to discussions
Expand all | Collapse all

Off Label Use of an Approved Drug Product In Combination with an Investigational Drug Product in a Clinical Trial

  • 1.  Off Label Use of an Approved Drug Product In Combination with an Investigational Drug Product in a Clinical Trial

    Posted 06-Oct-2016 15:14

    Hello Fellow RA Professionals,


    Would the off-label use of an approved drug product In combination with an investigational drug product in a clinical trial render the approved product an investigational drug product requiring clinical study labels applied locally at the clinical sites or centrally labeled?


    Thank you.


    David





  • 2.  RE: Off Label Use of an Approved Drug Product In Combination with an Investigational Drug Product in a Clinical Trial

    Posted 13-Oct-2016 00:13

    See 21 CFR 312(b)(iii) - it is investigational

    ------------------------------
    Samir Shah
    Miami FL
    United States

    Original Message