Yes, we use pre-submission 'submissions' and meetings frequently. They are a bit of a double-edged sword. On the one hand, they can be critical the ensure that the right strategy/classification is used. On the other hand, FDA can use it as another opportunity to 'recommend' studies well-beyond what the company had planned to undertake. Then, if the submission does not comply with the recommendations, FDA can really tie up the submission. There is a fine line between receiving effective guidance and receiving burdensome requirements.
We have used teleconference only. Note that our location makes casual visits to FDA impossible. We have never used other than a conference call - we have always had to pre-submit our questions with background. We usually provide a powerpoint presentation that we step through during the call with each end holding their own copy of the presentation. Questions much beyond those submitted have been deferred.
The teleconferences have never lasted longer than one hour - some as brief as 1/2 hour. We were asked to pre-identify who would be in attendance from our end and were informed in advance of the planned agency participants. There were usually three FDA attendees. There have sometimes been more FDA participants if there are different technical areas (e.g. statistics, software, clinical studies)
1. The person handling the pre-submission
2. A more technical expert in the area of questions
3. A manager.
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Debra Hutson
Manager QA/RA ELITechGroup Inc
ELITechGroup
Bothell WA
United States
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