Draft Guidance for formal meetings with the FDA between sponsors or applicants of PDUFA products dated September 2023. The new regime at the FDA is on video stating that they are actively engaging in face to face dialogue with sponsors. This guidance , to me, highlights why the last meeting with the FDA resulting in a very very positive announcement to refile the BLA- prior to receiving the official minutes
X. MEETING CONDUCT
635
636 Meetings will be chaired by an FDA staff member and begin with introductions and an overview
637 of the agenda. FDA policy prohibits audio or visual recording of discussions at meetings.
638
639 Presentations by requesters are usually unnecessary because the information necessary for
640 review and discussion should be part of the meeting package. If a requester plans to make a
641 presentation, the presentation materials should be provided ahead of the meeting. All
642 presentations should be kept brief to maximize the time available for discussion. The length of
643 the meeting will not be increased to accommodate a presentation. If a presentation contains
644 more than a small amount of content distinct from clarifications or explanations of previous data
645 and that were not included in the original meeting package submitted for review, FDA staff may
646 not be able to provide commentary.
647
648 Either a representative of the FDA or the requester should summarize the important discussion
649 points, agreements, clarifications, and action items. Summation can be done at the end of the
650 meeting or after the discussion of each question. Generally, the requester will be asked to
651 present the summary to ensure that there is mutual understanding of meeting outcomes and
652 action items.FDA staff can add or further clarify any important points not covered in the
653 summary, and these items can be added to the meeting minutes. At pre-NDA and pre-BLA
654 meetings for applications reviewed under the PDUFA Program for Enhanced Review
655 Transparency and Communication for New Molecular Entity (NME) NDAs and Original BLAs
(also known as the Program),
12 656 the requester and the FDA should also summarize agreements
657 regarding the content of a complete application and any agreements reached on delayed
658 submission of certain minor application components.
XI. MEETING MINUTES
662
663 Because the FDA’s minutes are the official records of meetings, the FDA’s documentation of
664 meeting outcomes, agreements, disagreements, and action items is critical to ensuring that this
12 See https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm327030.htm.
Contains Nonbinding Recommendations
Draft — Not for Implementation
17
665 information is preserved for meeting attendees and future reference. The FDA will issue the
666 official, finalized minutes to the requester within 30 calendar days after the meeting.
667
668 The following are general considerations regarding meeting minutes:
669
670 • FDA minutes will outline the important agreements, disagreements, issues for further
671 discussion, and action items from the meeting in bulleted format. The minutes should be
672 sufficiently detailed that they provide clarity about the agreements, such as on study
673 design elements, or statistical testing, or enrollment criteria and similar important areas of
674 the development program. The minutes are not intended to represent a transcript of the
675 meeting.
676
677 • FDA project managers will use established templates to ensure that all important meeting
678 information is captured.
679
680 • The FDA may communicate additional information in the final minutes that was not
681 explicitly communicated during the meeting (e.g., pediatric requirements, data standards,
682 abuse liability potential) or that provides further explanation of discussion topics. The
683 FDA’s final minutes will distinguish this additional information from the discussion that
684 occurred during the meeting.
685
686 • For INTERACT meetings, preliminary responses will be annotated and resent within 30
687 days if advice provided changes as a result of the meeting.
688
689 • In cases of a WRO, the WRO will serve as meeting minutes.
690
691 The following steps should be taken when there is a difference of understanding regarding the
692 minutes:
693
694 • Requesters should contact the FDA project manager if there is a significant difference in
695 their and the FDA’s understanding of the content of the final meeting minutes issued to
696 the requesters
697
698 • If after contacting the FDA project manager there are still significant differences in the
699 understanding of the content, the requester should submit a description of the specific
700 disagreements either:
701
702 ‒ To the application; or
703
704 ‒ If there is no application, in a letter to the division director, with a copy to the FDA
705 project manager
706
707 • The review division and the office director, if the office director was present at the
708 meeting, will take the concerns under consideration
709
Contains Nonbinding Recommendations
Draft — Not for Implementation
18
710 ‒ If the minutes are deemed to accurately and sufficiently reflect the meeting
711 discussion, the FDA project manager will convey this decision to the requester and
712 the minutes will stand as the official documentation of the meeting.
713
714 ‒ If the FDA deems it necessary, changes will be documented in an addendum to the
715 official minutes. The addendum will also document any remaining requester
716 objections, if any.
717
718 For input on additional issues that were not addressed at the meeting, the requester should submit
719 a new meeting request, a WRO request, or a submission containing specific questions for FDA
720 feedback.
721
722 For all meeting types, to ensure the sponsor’s understanding of FDA feedback from meeting
723 discussions or a WRO, sponsors may submit a “follow-up opportunity/clarifying questions”
724 correspondence to the agency in a formal submission to their application. Only questions of a
725 clarifying nature should be submitted (i.e., to confirm something in minutes or in a WRO issued
726 by the FDA) rather than new issues or new proposals. If the FDA determines that the requests
727 are not in scope (i.e., are not simply clarifications of advice provided at the meeting), the division
728 may advise the sponsor to request a new meeting to address the issue. However, if the out-of729 scope issue is narrow and focused, the review division, at their discretion, may provide a
730 response (as a general correspondence) as soon as reasonably possible. The clarifying questions
731 should be sent in writing as a “Request for Clarification” to the FDA within 20 calendar days
732 following receipt of the meeting minutes or WRO, to include if the preliminary comments serve
733 as the final minutes for a cancelled meeting. For questions that meet the criteria, the FDA will
734 issue a response in writing within 20 calendar days of receipt of the clarifying questions. The
735 FDA’s response will reference the original minutes or WRO.
These minutes may come early , within the 30 day period.
Permission to refile is HUGE given that the FDA had the new data prior to the meeting.
Would have gone three ways- No you cannot refile
- more information required
- Yes you may proceed
Monty Hall problem
First Door - NO , first CRL - old FDA
Second door- No, more information - changing FDA
Third door- last door standing- new FDA
Lets go meso
Reg
Expand
(20min delay)
