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  • 1.  Cross-Referencing to Another Application

    This message was posted by a user wishing to remain anonymous
    Posted 07-Sep-2018 10:26
    This message was posted by a user wishing to remain anonymous

    Dear Community-

    Is it possible to cross-reference to an unapproved NDA if you are the sponsor for that NDA?

    Thank you!


  • 2.  RE: Cross-Referencing to Another Application

    Posted 11-Sep-2018 12:58
    Yes. As an example, we submitted two NDAs at the same time for two different dosage forms of the same drug substance.  We included a complete Module 32S for the drug substance in one NDA, while in the second NDA we cross referenced to the other NDA for the drug substance information.

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    Tom
    Chicago
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    Original Message


  • 3.  RE: Cross-Referencing to Another Application

    Posted 12-Sep-2018 08:31
    Could you clarify whether you are thinking of cross-referencing an unapproved NDA (a complete response letter was issued), or an NDA under active review?  If the latter case, then yes you can.  If the first case, it will depend on the deficiencies identified in the CRL.

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    Glen Park
    Jersey City NJ
    United States
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    Original Message


  • 4.  RE: Cross-Referencing to Another Application

    Posted 13-Sep-2018 10:52

    Hello, you can cross-reference one approved NDA to another; however, unless OPQ has changed practices, the NDA doing the cross-referencing cannot be approved before the crossed-referenced NDA.  Thus, there is risk in this strategy.  An alternative strategy when referencing drug substance (DS, API) information is to place the DS information in a Drug Master File (DMF).



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    Terrance Ocheltree PhD, RPH
    PharmTree Consultants, LLC

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    Original Message


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