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  • 1.  How to submit FDA meeting minutes an amendment to supplemental Pre-sub

    Posted 09-Sep-2019 01:25
    Hello All,

    I have been involved with FDA meeting at my work.I have to submit the Pre-sub meeting minutes to FDA within 15 calendar days like an amendment to the supplemental Pre-sub submission.
    Can you give some details like, Is the meeting minutes need to be submitted in MS word document or PDF?
    •  Submission should be a paper copy and an ecopy ( as per guidance, i see as we need 2 copies)? Is my understanding right?
    • And, How to submit an amendment to the supplemental submission?


    Thank you,
    Yamini Nidumolu

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    Yamini Nidumolu
    Bellevue WA
    United States
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  • 2.  RE: How to submit FDA meeting minutes an amendment to supplemental Pre-sub

    Posted 10-Sep-2019 08:45
    A good description can be found in the draft guidance Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. (https://www.fda.gov/media/114034/download)

    In short, submit a Word document that will allow FDA to edit the minutes.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: How to submit FDA meeting minutes an amendment to supplemental Pre-sub

    Posted 10-Sep-2019 11:09
    Hi. Just send in one ecopy as a PDF. You don't need to send in a paper copy.  In the cover letter just say it is an amendment to pre-Submission Qxxxx/Syyyy.  FDA may email you and ask for a word version (especially if they plan to edit the meeting minutes).

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    Elisabeth Neely RAC
    Sr Vice President, Clinical and Regulatory Affairs
    Houston TX
    United States
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    Original Message


  • 4.  RE: How to submit FDA meeting minutes an amendment to supplemental Pre-sub

    Posted 11-Sep-2019 23:41
    Edited by Isabella Schmitt, RAC 11-Sep-2019 23:44
    I typically send the ecopy as a PDF on a flash drive and also send a paper copy to the DCC within the 15 day timeframe. Paper may be optional and not eco-friendly though. One thing to note- make sure that the flash drive doesn't have any hidden files.

    I also send a PDF and a word version to my lead reviewer via e-mail. However, we typically discuss this during the meeting.

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    Isabella Schmitt
    Regulatory Affairs Consultant
    Houston TX
    United States
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    Original Message


  • 5.  RE: How to submit FDA meeting minutes an amendment to supplemental Pre-sub

    Posted 13-Sep-2019 06:11
    I can tell you from my recent experience, I send in the meeting minutes in PDF via eCopy only.  (It will be great at the point where we can just submit documents like these via email.) Then I send a Word version to the lead reviewer via email.  Because what happens is they take your PDF, unlock it, put it back into Word format to do the redline.  So already if I send them the Word version they can work directly with the native document.  If you lock down the PDF through Adobe, that will get delayed also because they will then need to request a Word version to redline (if needed).

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


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