Regulatory Open Forum

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  • 1.  PAI date

    Posted 11-Mar-2013 10:15
    Hi All,

    In terms of timeframe, when should a firm expect a PAI? Please share your experience.

    Context: NDA submission, first application, NME.
    FDA review target goal (PDUFA V): 10 months within the 60 day filing.

    Can I assume 4 months before final decision (approval of application) is made is a good estimate? Have you experienced sooner and/or later PAI?

    Regards,

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    Tom Namsavanh RAC
    Manager, Regulatory Affairs and Compliance
    Intelgenx Corp.
    Saint-Laurent QC
    Canada
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  • 2.  RE:PAI date

    Posted 12-Mar-2013 10:10
    With CDER's emerging GRMPs, the center suggests that PAI be made early in the review cycle, ideally, prior to the filing for full review. Thus, chances are that CDER may request PAI following an initial assessment of the NDA, before they complete full assessment for the filing decision.

    PAI of foreign and domestic sites are both conducted on a pre-announce basis.

    If you want to read more, CDER's guidance--Compliance Program Guide 7346832 should help you with most of your questions.

    Best
    Calvin


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    Calvin Lei Shi
    Dorchester MA
    United States
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