Regulatory Open Forum

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  • 1.  purchasing drug for investigation

    This message was posted by a user wishing to remain anonymous
    Posted 06-Sep-2018 09:07
    This message was posted by a user wishing to remain anonymous

    How do you purchase a prescription drug for investigational use for an unapproved condition (drug is unapproved for that indication) in the following scenarios?

    1. Drug is on patent
    2. Drug is off-patent

    Thanks


  • 2.  RE: purchasing drug for investigation

    Posted 07-Sep-2018 09:08
    First, it is a complicated issue and many aspects to consider. However, the simple answer to the practical act of purchasing the drug is to have a clinical trial supply company purchase it from a commercial supplier. 

    The more complicated answer depends on what you plan to do with the product. And, the answer to all of the possible scenarios of indication, approval, patent status, exclusivity status, quality information, nonclinical support for the new indication, IND requirements, etc., is what regulatory consultants get paid big bucks to sort out.

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    Glen Park
    Jersey City NJ
    United States
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