Regulatory Open Forum

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  • 1.  Re

    Posted 02-Aug-2018 11:34
    Hi all,
    I am not sure but I thought that I had read in some discussion that you can request the FDA meeting records of pre-sub meetings. Is that correct and if yes, how do I apply for these records?

    Thanks,
    Melanie

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    Melanie Martini
    Berlin
    Germany
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  • 2.  RE: Re

    Posted 03-Aug-2018 09:45
    They should be public records and I would anticipate you can get them via an FOIA request. Be specific "all records related to the Q-sub meeting between FDA and XYZ company on [full date].

    Given that the records are of your meeting, it shouldn't need redaction time and shouldn't take forever.

    g-

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    Ginger Glaser RAC
    Chief Technology Officer
    MN
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    Original Message


  • 3.  RE: Re

    Posted 06-Aug-2018 06:11
    Hi Ginger,
    Thanks for the information. Do you have experience regarding Q-sub records? Do the records provide more information than the ones the meeting participants have on hand already? I am referring to e.g. internal FDA discussions about the meeting or FDA decision making after the meeting?

    Best.

    ------------------------------
    Melanie Martini
    Berlin
    Germany
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    Original Message


  • 4.  RE: Re

    Posted 07-Aug-2018 15:27
    I've requested a few. In the past they came rather slowly - we were told "because FDA has no way of tracking them." We were hoping recent ones (now that Qsub is formally in MDUFA 4 commitment letter) but so far no such luck.

    As to value, it varied. I've gotten pretty much only what they officially put into their response letter and our meeting minutes. But I've also gotten meeting minutes from their prep meetings, which were a bit more informative.

    g-

    ------------------------------
    Ginger Glaser RAC
    Chief Technology Officer
    MN
    ------------------------------

    Original Message


  • 5.  RE: Re

    This message was posted by a user wishing to remain anonymous
    Posted 06-Aug-2018 11:30
    This message was posted by a user wishing to remain anonymous

    I attempted this very same thing some months ago via an FOIA request but have heard nothing. Since the materials requested were for my current employer, I did not think this would be a problem or that it would take long but I was wrong.
    Original Message


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