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  • 1.  FDA Pre-submission - urgent advice

    Posted 19-Apr-2021 20:31

    Hi ,

     

    Needed urgent advice on this situation ,

     

    We had submitted the Pre-sub to the FDA a month ago, are awaiting the feedback. There has been a development in the meanwhile where the competitor information gets updated by the FDA and it relates to the information we have included in our pre-sub for feedback. There's a change in the scope of the Pre-sub now. What could we do now, wait for the feedback to submit a supplement or get an amendment in ? As we have also chosen meeting through telecon as the method of feedback , is this something to discuss during the meeting?

     

     

    Thanks & Regards,

    signature_1537400070

    Rashmi Pillay

    Regulatory Affairs Manager

    Ellex – Lumibird Medical group

    3-4 Second Ave, Mawson Lakes SA 5095
    Tel. +61 8 7074 8105

    Email rpillay@ellex.com

     

     

     

     

     

     

     

     

     

     

     

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  • 2.  RE: FDA Pre-submission - urgent advice

    Posted 20-Apr-2021 04:06
    Hi Rashmi:
    The key to a good Pre-Sub is asking focused questions to get the information you really need from FDA. So the key criteria for deciding what to do are: does the new information change any question posed (or its value to me ), and, is the new information likely to change FDA Response in a way that changes the value of their answer to me? If you meet either of these criteria, I suggesting contacting DICE and explaining the situation: either you wish to delete/amend/extend one or more questions in the light of new information, or, you wish to provide new information to FDA as you think it might be pertinent to their response. They can see what stage your Pre-Sub has reached and the best way and the best way to communicate with the review team. They can advise you to withdraw and re-submit, supplement the existing submission or leave it as it is and the best process to follow. The correct approach may depend on the workload of the particular branch and how close they are to responding and DICE can really help you on this.
    Good luck!
    Neil
    PS make sure you/your team are prepared for the call with FDA and ideally rehearse it. How will you respond to what you think FDA might say, what might they have misunderstood from your submission and how to do you handle that situation.

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    Neil Armstrong FRAPS
    CEO MeddiQuest Limited
    Peterborough
    United Kingdom
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    Original Message


  • 3.  RE: FDA Pre-submission - urgent advice

    Posted 20-Apr-2021 04:09
    Hello Rashmi,

    Once a Q-Submission request has gone in, it is difficult to supplement or amend until you know the reviewer who has been assigned.  You can send in a supplement to your Q-Submission request, but this might create more confusion than creating clarity about any change.  My recommendation is once you start having discussion with the reviewer, advise them then if you make a change.  More importantly, currently today the FDA's Q-Submission is very back-logged and they are prioritising Q-Submission.  If you have chosen telephone for method of feedback you are probably going to be waiting at least 6 months.  In fact, FDA has even "rejected" some Q-Subs now because they do not have time or resources.  There was another post on the forum about this a couple months back, but not sure anything has really changed yet.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: FDA Pre-submission - urgent advice

    Posted 20-Apr-2021 08:13
    Thanks Neil, Richard

    We have been assinged a reviewer and have the meeting date , next month . Should we contact the reviewer directly in light of the new information ?

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    Rashmi
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    Original Message


  • 5.  RE: FDA Pre-submission - urgent advice

    Posted 20-Apr-2021 09:47
    HI Rashmi,
    I'd suggest you reach out to the RPM (FDA project manager who gave you the Q number and date of meeting) and tell her/him that you'd like to add a bit more detail to the meeting and a few additional questions and ask them how they suggest you proceed. I've seen in the past where if the meeting is still 50+ days out they will allow an expansion without pushing your meeting back. If the meeting is <30 days from now, they are likely to tell you to send in supplement (technically its not a supplement given you have not had the meeting yet but it's also not an amendment given its new information) and they will set a new date (at least another 30 days out) so they have time to read the content and meet to discuss the content before the meeting. 
    The more clear you can be on how much new content and how many new questions the easier it will be for FDA to give you a response. 
    Good Luck!


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    Isabel McGann, MS, RAC
    Regulatory Program Manager
    Westminster. CO
    United States
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    Original Message


  • 6.  RE: FDA Pre-submission - urgent advice

    Posted 20-Apr-2021 11:10
    You've gotten some great advice here and I agree with that. My additional thought is that I would like to think that the reviewer is aware of the competitors product situation. Therefore, you just have to make sure that you and your review team are on the same page on that. But it's possible, especially with everyone working remotely now, that the team doesn't know what you know about your competitor. So make sure your meeting includes sharing information so that you're all on the same page about that. I hope the team already knows. That will make it easier for all of you.

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    Andrea Chamblee Esq., RAC, FRAPS

    This information and views expressed are provided in my capacity as an FDA and compliance professor at Johns Hopkins and George Washington universities, and do not necessarily represent the official views of the agency or the United States. Consult the Agency for an official position.

    Silver Spring MD
    United States
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    Original Message


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