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  • 1.  Expanded access for investigational product outside US

    Posted 09-Dec-2017 11:56
    ​​Looking for comments on expanded access (single patient IND filing) for a treatment that is being evaluated in Spain.  The treatment is being evaluated in Spain and we would like to like to file a treatment IND with the FDA for a single patient.  Besides Form FDA 3926, what else is needed for FDA review/approval? 

    Comments appreciated....

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    Uday Patel RAC
    Regulatory-Quality Consultant
    Alpharetta GA
    United States
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  • 2.  RE: Expanded access for investigational product outside US

    Posted 11-Dec-2017 08:57
    For FDA, all information needed is provided in the following guidance documents.  

    https://www.fda.gov/downloads/drugs/guidances/ucm351261.pdf
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    View this on Fda >


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    Glen Park
    Scynexis, Inc.
    Jersey City NJ
    United States
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    Original Message


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