Draft Guidance for formal meetings with the FDA between sponsors or applicants of PDUFA products dated September 2023.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
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