Regulatory Open Forum

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  • 1.  Rolling Review and PAI

    Posted 16-Feb-2016 19:01

    Hi

    I have a practical question that I am hoping someone has an experience with please.  If you were in a Rolling Review situation with FDA for an NDA, and had submitted your Module 3 ahead of the other Modules - would this trigger the PAI of the manufacturing/labs shortly afterwards?  Or would the PAI be scheduling following the submission of the last part of the NDA?  

    Any thoughts people can share would be welcomed.

    Many Thanks
    Sue

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    Sue Evans MBA
    Manager Regulatory Affairs
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  • 2.  RE: Rolling Review and PAI

    Posted 17-Feb-2016 07:32

    Sue,

    I have seen it both ways. I've submitted a CMC section and it did set off a PAI. In this case the facility was due inspection, in my opinion the PAI was added to the normal inspection cycle. I have also seen that the submission of module III never set off a PAI because the facility had gone through a successful FDA audit. In my opinion it has to do with more of the inspection cycle that your company is in.

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    John Lay
    Director, Regulatory and Quality
    Vistapharm Inc.
    Largo FL
    United States

    Original Message


  • 3.  RE: Rolling Review and PAI

    Posted 17-Feb-2016 08:32
    Sue,

    John provided good info.

    It would be helpful to have a chance to learn about how FDA schedules PAIs per CPGM (under Part III Inspection Scheduling and Preparation).  

    Based on various factors (your facility's readiness for an FDA inspection, application type, for cause, etc.), FDA tries to carefully weigh the need for the inspection "to provide an early contribution to the application review process."

    Thank you.  

    s/ David
    ______________________________________________
    Dr. David Lim, Ph.D., RAC, ASQ-CQA 
    Phone (Toll-Free): 1-(800) 321-8567



    "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

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    Original Message


  • 4.  RE: Rolling Review and PAI

    Posted 17-Feb-2016 09:01

    Having experienced this ~11 years ago, the agency waited until all of the sections were in before performing the PAI.   I am not sure what the current experience/trends are however.

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    Donald Kruppa RAC
    Vice President, Program Management and Logisitics
    ZS Pharma Inc.
    Coppell TX
    United States

    Original Message


  • 5.  RE: Rolling Review and PAI

    Posted 18-Feb-2016 11:40

    Thanks everyone - it does seem like there isn't a hard & fast rule on this topic. I did wonder if it might depend on when the facility had been last inspected (with good standing).  Something to consider nearer the time I think.

    In the meantime, many thanks for your input - very valuable!

    Have a great day
    Sue 

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    Sue Evans MBA
    Manager Regulatory Affairs


    Original Message


  • 6.  RE: Rolling Review and PAI

    Posted 22-Feb-2016 16:40

    Dear Sue,

    If case if your rolling NDA comes under expedited review, have your facility ready for the inspection.

    Best,

    Shahid Hussain

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    Shahid Hussain
    Allston MA
    United States

    Original Message