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  • 1.  Rescue Medication Label Req. In Clinical Trials

    Posted 15-Apr-2021 23:27
    Hello- Please if someone could help me with any guidance documents on approved rescue medication being used in clinical trials in the US. What are the labeling requirements? I believe protocol number would be one to begin with. Indeed, retaining the manufacturers label. Sourcing medication from US & ex-US.

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    Best Regards,
    Nikita Kathpal, MS
    Regulatory Officer II, USA & Canada

    Pharm-Olam International
    450 N. Sam Houston Parkway, E. Suite 250
    Houston, TX 77060

    Email: nikita.kathpal@pharm-olam.com
    Direct line: +1 713-559-7964
    Main: +1 713-559-7900
    Ext. 11164
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  • 2.  RE: Rescue Medication Label Req. In Clinical Trials

    This message was posted by a user wishing to remain anonymous
    Posted 16-Apr-2021 09:54
    This message was posted by a user wishing to remain anonymous

    If you are planning to use approved rescue medication, you could use the same approved label! Its a rescue medication so there is nothing to look for except in the case of sourcing it from two different countries! As long as the drug product is the same including same site of manufacture then no issue for your trial.
    Original Message


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