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What is the format of a Q-Submission meeting?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

During a Q-Sub meeting, FDA will be prepared to discuss the contents of the Q-Sub as well as any written feedback the Agency has already provided. Please note that the FDA is generally unable to comment on new information provided by the submitter between receiving FDA written feedback and holding the meeting or during the meeting. If a submitter would like feedback on new information, such a request should be submitted as a supplement to the Q-Sub to allow adequate time for review, written feedback, and discussion of the new material, as appropriate. Submitters should provide draft slides to FDA electronically (e.g. in Microsoft PowerPoint or PDF) at least two (2) days before the meeting. This will allow adequate time to distribute the presentation to all participating FDA staff.

Submitters that request a meeting should be aware that all meetings are subject to disclosure review pursuant to the Freedom of Information Act (FOIA). Meeting minutes and materials, like all Agency records, may be the subject of a FOIA request and unless the information being requested is classified as commercially confidential or trade secret, it will be released to requesters.

a) Meeting Format

If desired, FDA is available to meet in-person or via teleconference. Generally, teleconferences may be more easily scheduled. While in person meetings may take longer to schedule due to conference room or staff availability, they can also be helpful depending on the situation (e.g. in providing live demonstrations), and some submitters may prefer them. For an in-person meeting, you should inform the lead reviewer or meeting coordinator of any audiovisual equipment you will need, such as conference phone or LCD projector or similar. The meeting coordinator or lead reviewer will reserve the room and arrange for any audiovisual equipment you may have requested. If internet access is needed for the meeting, visitors must make this request at least five (5) days prior to the meeting.

Please note that one (1) hour is adequate for most meetings. If you believe that more than one hour is needed, a rationale should be provided for the duration you propose. You should also refer to that rationale and confirm the duration requested when the meeting coordinator or lead reviewer schedules your meeting.

b) Meeting Attendees

Generally, FDA attendees will include members of the FDA review team (including consultants from other Offices or other Centers), and the first line manager. You can help to ensure that appropriate FDA staff is present by suggesting that certain types of experts attend, depending upon the specific questions or issues that you wish to address.

All non-U.S. citizens attending a meeting in an FDA facility are subject to additional security screening. You should inform the meeting coordinator or lead reviewer prior to the meeting date and work with them to ensure the appropriate information is available and provided. It generally takes about two weeks to process requests for foreign visitors.

You are invited and encouraged to include any additional outside individuals (e.g. Centers for Medicare & Medicaid Services (CMS), private payers, NIH grant reviewers) in your Q-Sub meetings, as appropriate. You are responsible for any additional attendees that you wish to invite and defining their roles and/or participation during the meeting.

c) Meeting Minutes

The submitter is responsible for drafting meeting minutes for all Q-Sub meetings. You should have a member of your team assigned to take meeting minutes, to be provided for FDA review following the meeting. CDRH and CBER policy is not to allow outside parties to record (by audio or video) meetings with staff in order to prevent interference with the free exchange of information.

The draft meeting minutes should be submitted to FDA as an amendment to the Q-Sub through the appropriate DCC within 15 days of the meeting. If slides were presented, the actual version used in the meeting or teleconference should be included with the draft minutes in the amendment. Submission of the meeting minutes as a formal amendment is intended to ensure appropriate tracking of the meeting minutes and documentation in the official record. In addition to the official meeting minutes submitted to the DCC, the submitter is encouraged to submit an identical version of the meeting minutes in a format that facilitates editing and commenting (e.g. Microsoft Word) under the miscellaneous files section of the eCopy package.

The meeting minutes should be an accurate reflection of the meeting discussion. Rather than being a transcript of the meeting, the minutes should summarize the meeting discussion, document how substantial or complex issues were resolved, and include agreements and any action items. Additional information or follow-up items that were not part of the meeting discussion should not be included in the meeting minutes.

If FDA does not have any edits to the draft minutes, the minutes will be considered final and FDA will communicate acceptance of the minutes via email. If FDA does edit your draft minutes, FDA intends to email the revised version of the minutes to you within 30 days. Minutes edited by FDA will become final 15 days after you receive FDA’s edits, unless you indicate to FDA that there is a disagreement with how a significant issue or action item has been documented. If such a disagreement exists, you should submit an amendment to the Q-Sub through the appropriate DCC, labeled as a “meeting minutes disagreement.” In the case of a disagreement, the FDA will set up a mutually agreeable time for a teleconference to discuss that issue. At the conclusion of that teleconference, within 15 days, FDA will finalize the minutes either to reflect the resolution of the issue or note that this issue remains a point of disagreement.

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