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  • 1.  Pre-Submission meeting with FDA

    This message was posted by a user wishing to remain anonymous
    Posted 12 days ago
    This message was posted by a user wishing to remain anonymous

    Dear all,

    I would like to hear your experience with the meetings held with FDA in the frame of pre-submissions request, such as:

    • how many days before the online meeting you did receive the FDA feedback letter
    • how did you organize the agenda of the meeting in terms of time to dedicate to the topics? 
    • how much time did you have dedicated to the company and people presentation?
    • was the meeting held all by one person or different functions alternated in the presentation?
    • could you share an appropriate agenda to propose you experience it works with FDA expectations?

    Many thanks!

  • 2.  RE: Pre-Submission meeting with FDA

    Posted 11 days ago

    Without specifically knowing your circumstances or the nature of the pre-sub, it is difficult to be very specific.  However, to answer some of your questions - I have typically received FDA written feedback several business days before the meeting, frankly often on a Friday before like a Tuesday or Wednesday meeting.  This can be quite stressful, I will note.  Get your team prepared for a blitz of preparation work just before the FDA meeting. 

    I have usually taken the FDA feedback and quickly looked through it myself to see if I have any gut reactions to the feedback - if you were looking for a particular answer to a key question, was it answered?  Did you get the answer you hoped?  What is the overall tenor of the response - is the feedback helpful?  Is there a general feeling that FDA is agreeing with your approach or plan (depending on content, of course)?  I usually then take the FDA response and send it to the key resources within my company and management, summarizing any key points (so management, for example, gets the overall sense of the response without having to read it).  I then put together a plan to meet with the team that day or the next day to talk to your subject matter experts on their impressions of the FDA feedback. 

    With the team, try to narrow down which feedback is leaving you with more questions or concerns.  Which feedback may not have gone in the way you hoped.  Figure out which items are most crucial to talk through with FDA during the meeting.  I will say the usual hour long meeting goes terribly quickly and you often can only touch on a couple larger topics during the meeting.  Hopefully you have a sense from the feedback which topics are more controversial for you and FDA than others.  Prioritize your topics for discussion based on this assessment with your SME team.  There may be some feedback that is straight-forward and you have no follow up questions or need for rebuttal.  No reason to even review these during the meeting.  What you want is a short list of topics for the meeting.  Get your team aligned on talking points for these, whether that means requests for clarification, for example, or a rebuttal to a response.  Put them in order of importance to your company - get the most critical ones up front in the meeting... again, an hour goes quickly and you may not get to all your desired topics.  Don't feel like you need to address the responses in the order of the original request.

    For the meeting agenda and planning, this could depend a lot on the team and their strengths, etc.  Depending on the time allotted to the meeting (typically an hour in my experience) and the subject matter and key topics for discussion, you may or may not want to start with a company presentation (of the company origins, device overview, etc.).  Although it can be nice to give FDA a feel for your company, you don't want to miss the opportunity to discuss your chosen topics.  Building that relationship with FDA though is certainly a key outcome for the meeting, so don't miss the opportunity, if you have time, to help them understand and appreciate how your company got to the point it has and, I assume, the great (possibly life-saving) technology you are pursuing.  In any case, I would rarely spend more than 10 minutes on a company and device overview and people introductions, unless this is one of the key reasons for the meeting (like your company's very first meeting with FDA).  A typical agenda for me is:

    • Introductions (if you already know the review team and they know your team - skip this)
    • Company and device overview (if there is time and you haven't already presented this to FDA)
    • Discussion of FDA written feedback (listing specific subset of topics you want to discuss, in the order you want to discuss them, planning to perhaps not hit them all)
    • Final Comments (I like to give FDA a chance to provide any key feedback from their perspective, in case you didn't discuss it as part of your main concerns)
    • Next Steps (future pre-submission on one of the topics or a new topic related to your device development or just timing of your next submission)

    As to the organization of the meeting and who attends/presents, that is very specific to your company.  I have typically had a single person be the overall spokesperson for the company, someone that understands the regulatory nuances of the discussion as well as the technical issues the company is trying to address.  That person would then pull in subject matter experts as needed to help with detail or to answer FDA follow-up questions.  If you don't have that in a single person, at least have a facilitator that will introduce each topic, ask the subject matter expert to discuss the topic from the company's point of view, summarize any key outcomes from the discussion of each topic, and watch the clock to move things along as needed.  Sometimes, if you're not getting anywhere with a certain topic, you just have to say that the company will take all the FDA feedback into consideration and will come back to FDA for any further discussion, if needed.  It is sometimes more important to move to the next key topic... then again, sometimes it's important to put an issue to bed.  You have to think about this prior to the meeting.  Practice with your internal team.  Plan your response to likely FDA responses with back up plans in case you don't get the answer you want.  Identify which SMEs should do more talking and which should do less talking.  Pull together a slide deck to help you organize your thoughts, key topics, etc.

    The day before the meeting, I typically provide FDA with the agenda (importantly the list of topics you want to discuss), planned attendees (especially if different from those provided in the original request), and a presentation with any key requests for clarification or rebuttals.  Remember that FDA will ask you (the company) to prepare meeting minutes and submit them to FDA within 15 business days.  Ensure you have everyone taking notes - especially those doing less talking.

    Anyway, hope that helps!  Best of luck with the meeting.

    Douglas Ferguson
    VP, Clinical and Regulatory
    Beta Bionics, Inc.
    Concord MA
    United States

  • 3.  RE: Pre-Submission meeting with FDA

    Posted 11 days ago

    I feel that Douglas has nailed it!

    As outlined - I agree its very important to understand the risks that the organisation is trying to mitigate, the strategy that will be employed for these risks and how that will be articulated to the FDA. Also, what everyone can live with in contrast to what are potential areas of true concern if not agreed with the FDA.

    With any meeting the message can sometimes be heard differently across the attendees so, as mentioned, I also feel it is very important (before the meeting finishes) to paraphrase the FDA's advice back to them to check accuracy of interpretation.

    Any opportunity to meet with a regulatory agency can provide invaluable insight into expectations for development and registration so it is paramount to prepare as well as humanly possible and orchestrate it well - in my opinion!



    Alexis Cockroft
    Lex Regulatory Ltd
    United Kingdom

  • 4.  RE: Pre-Submission meeting with FDA

    Posted 10 days ago

    Suggest you review the guidance "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products" issued Sept 2023 (rev 1) which lists all timelines and has example agenda. FDA can issue their Preliminary Comments 1-3 days before meeting - then you can narrow your discussion to those agenda items that warrant further discussion. I would not spend any time on introductions unless there have been any changes to the list of participants in your briefing document. No need to give any company presentation. Plan to dive right into the agenda item sand questions. You should have a point person (usually Regulatory) leading things from Sponsor side. You can direct any questions from FDA to the appropriate subject matter expert from Sponsor team. Keep things moving and on track. The 1 hour is not much time and you want to use wisely. Leave 5 min at end to summarize any agreements. Suggest you send FDA your meeting minutes quickly as they can help inform FDA's Meeting minutes which are the official minutes of the meeting.

    Tom Stothoff
    Senior Director, Regulatory Affairs CMC

  • 5.  RE: Pre-Submission meeting with FDA

    This message was posted by a user wishing to remain anonymous
    Posted 9 days ago
    This message was posted by a user wishing to remain anonymous

    This could differ between FDA offices and companies.

    • Typically, we receive the feedback by the time in the guidance. You can also see an estimate in the FDA portal if you submitted through the portal. They have been good at aligning with the estimates lately.
    • We keep intros short and instead provide a slide in advance with name and department so they know who is there. We each say our name the first time we speak.
    • We might have a few background slides reiterating what was sent in writing especially if that's helpful for the open questions, and then we go to the open questions - those with feedback from FDA. Don't bother with the questions where you agree. Just state you understand.
    • We have one lead representative from Regulatory, one coordinator who fights with the call set up hiccups and takes notes, and whatever functions are needed for the topics related to the open questions. The lead describes the background slides and introduces functional experts when we feel it makes more sense for that expert to describe a slide. The lead is the primary person to answer questions and also signals each of us when a different person should answer a question.