Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with a face to face pre-submission meeting with FDA?

I understand the presentation is required to be sent to the FDA 2 days before the meeting. What does the presentation need to include   ( in addition to the briefing package which has already been submitted)?  What are the ways that a face to face is effective ? Does the FDA ask questions that we need to be prepared with ?

Hi Anon.

I have only had one F2F meeting so my experience is limited but yes you prepare a presentation. Your presentation will be based on the feedback that you receive from your pre-submission package / the questions that you asked. You cannot work on this until you receive the feedback so you normally need a fairly quick turnaround on submitting this to the FDA.

In my... limited experience, I found the FDA very helpful and they want to help you so don't be afraid to get the most out of the meeting!

The FDA will not ask you questions beforehand, they just provide the feedback. Your meeting might present some questions that are ad-hoc but you obviously cannot prepare for this. 

Hope this helps.

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James
Head of QARA
UK
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Original Message:
Sent: 12-Jan-2020 17:00
From: Anonymous Member
Subject: Pre-submission meeting face to face

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with a face to face pre-submission meeting with FDA?

I understand the presentation is required to be sent to the FDA 2 days before the meeting. What does the presentation need to include   ( in addition to the briefing package which has already been submitted)?  What are the ways that a face to face is effective ? Does the FDA ask questions that we need to be prepared with ?

Hi anonymous,

As James said, include slides on major discussion points and follow-up questions you have on the pre-submission memorandum that the lead reviewer provided you. In my experience, it is crucial to get agreement on your study design(s) and other submission-related content. Though the pre-submission isn't binding on you or the FDA, I've been able to address a lot of RfAI issues by referring the reviewer to agreements reached during the pre-sub. Make sure you take good meeting minutes!

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Jeffrey Freedman
Regulatory Affairs Specialist II
Lowell MA
United States
------------------------------

Original Message:
Sent: 12-Jan-2020 17:00
From: Anonymous Member
Subject: Pre-submission meeting face to face

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with a face to face pre-submission meeting with FDA?

I understand the presentation is required to be sent to the FDA 2 days before the meeting. What does the presentation need to include   ( in addition to the briefing package which has already been submitted)?  What are the ways that a face to face is effective ? Does the FDA ask questions that we need to be prepared with ?

This message was posted by a user wishing to remain anonymous

Hi anonymous,
I've also only had one experience with a face-to-face meeting but our approach was basically to give a brief overview of the system, mostly reiterating what was provided in the pre-sub itself.  We also gave a demonstration of the device, which was extremely beneficial because FDA was struggling to understand the mechanics of it through our previous discussions.  We also included some slides that addressed FDA's responses to our questions from the pre-sub.  And lastly, we included some additional questions for FDA based on the overall discussion/presentation.

So the presentation itself isn't required to include anything specific, just whatever information your company feels needs to be addressed in order to have an effective meeting.  But keep in mind, your time with FDA is limited, so your presentation should not take up more than half that time (even less if possible) in order to allow for questions from FDA and additional discussion.  Another thing to note, the presentation should not introduce any new information that FDA hasn't already reviewed in the pre-sub.  

FDA was very engaged in our meeting, and left us feeling like FDA was willing to work with us (it's sometimes difficult to get that feeling from written feedback/phone conferences).  So overall, if presentation addresses all of the points you feel are important and you are willing to have an open discussion with FDA, your meeting will be effective and provide you with a clear path moving forward.
Original Message:
Sent: 12-Jan-2020 17:00
From: Anonymous Member
Subject: Pre-submission meeting face to face

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with a face to face pre-submission meeting with FDA?

I understand the presentation is required to be sent to the FDA 2 days before the meeting. What does the presentation need to include   ( in addition to the briefing package which has already been submitted)?  What are the ways that a face to face is effective ? Does the FDA ask questions that we need to be prepared with ?

As with all else, the answer is "it depends" - much depends on what is driving the need for the Qsub meeting. For instance, if it is specific to questions on the clinical protocol, your presentation might be centered on the reasons for certain aspects of the protocol. That said, if this is a general "first" pre-sub, I generally make sure our presentation includes the following:

- overview of the device (this is a chance for you to really make sure the reviewer understands it)
- summary of the questions you submitted and the feedback you received. to the extent you agree - say so
- background and discussion on any remaining key issues - in particular if any FDA feedback seems unclear, overly burdensome or scientifically incorrect, this is your opportunity to provide more clarity

Use these to drive discussion - listen to FDA feedback and note WHO is giving the feedback. Have your technical people provide more details where needed - though FDA will come in with a position, often the technical conversation can set you up for a shift later on.

g-

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Ginger Glaser RAC
Chief Technology Officer
MN
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Original Message:
Sent: 12-Jan-2020 17:00
From: Anonymous Member
Subject: Pre-submission meeting face to face

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with a face to face pre-submission meeting with FDA?

I understand the presentation is required to be sent to the FDA 2 days before the meeting. What does the presentation need to include   ( in addition to the briefing package which has already been submitted)?  What are the ways that a face to face is effective ? Does the FDA ask questions that we need to be prepared with ?

This message was posted by a user wishing to remain anonymous

I typically do not use presentations at meetings with health authorities. All the material you want to share with them should have been in the briefing document 75 - 90 days prior to the meeting. Expect that FDA has thoroughly reviewed the document and have answers to your questions. If you are lucky, FDA will provide responses to your questions a few days before the meeting. Your goal should be to precisely understand what FDA is telling you, what is rigid vs what type of data you need to provide. So rather than focus on a presentation, you should focus on how FDA might respond to your questions, and what additional questions you will seek to understand them better.
Original Message:
Sent: 12-Jan-2020 17:00
From: Anonymous Member
Subject: Pre-submission meeting face to face

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with a face to face pre-submission meeting with FDA?

I understand the presentation is required to be sent to the FDA 2 days before the meeting. What does the presentation need to include   ( in addition to the briefing package which has already been submitted)?  What are the ways that a face to face is effective ? Does the FDA ask questions that we need to be prepared with ?

The intent of a PreSub meeting is generally to clarify FDA's written feedback and resolve any issues on misunderstood PreSub content (such as clarification of test plans). This is typically done through a prepared presentation that is sent in a couple of days before the meeting, and includes:

1. Product overview
2. Meeting attendees (FDA and your company's)
3. Your response to FDA's written feedback (point by point) and any remaining questions you have for FDA on those points

Note that generally you should not introduce new content that wasn't already in the PreSub. Any significant new content should be submitted as a PreSub supplement.

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Hiral Dutia
Waltham MA
United States
------------------------------

Original Message:
Sent: 12-Jan-2020 17:00
From: Anonymous Member
Subject: Pre-submission meeting face to face

This message was posted by a user wishing to remain anonymous

Hi,

Does anyone have experience with a face to face pre-submission meeting with FDA?

I understand the presentation is required to be sent to the FDA 2 days before the meeting. What does the presentation need to include   ( in addition to the briefing package which has already been submitted)?  What are the ways that a face to face is effective ? Does the FDA ask questions that we need to be prepared with ?