In December 2015, the FDA released a draft guidance, which provides IND sponsors with a number of recommendations and best practices for communicating with the FDA. Among those included in the draft guidance are the following best practices for meeting-related communication with FDA:
- Before requesting a meeting with FDA, sponsors should use the expansive sources of drug development information that are publicly available. See section VII.I., Resources for Sponsors.
- Sponsors are encouraged to request feedback via formal meetings with FDA at the major drug development milestones described above. FDA typically grants meeting requests at these major milestones.
- Sponsors should only submit milestone meeting requests when drug development has progressed to the point where a full discussion of issues germane to that development stage is possible. Premature meeting requests are often denied by FDA.
- In lieu of a traditional meeting with FDA (i.e., face-to-face or teleconference), sponsors also can seek feedback through WRO requests, specifically for pre-IND feedback and feedback that would otherwise have been requested in a Type C meeting request. To conserve resources, FDA may also exercise discretion in converting a traditional meeting request for a pre-IND or Type C meeting to WRO responses. The number of questions posed in a WRO request should be no more than what would be reasonably expected to be addressed in a traditional meeting’s allotted duration.
- Sponsors should outline the purpose of the meeting in the meeting request.
- Sponsor’s meeting requests should include their preferred dates and requested FDA attendees. FDA project managers should take these preferences into consideration when scheduling meetings.
- Sponsors should try to anticipate future needs and, to the extent practical, combine discussion of drug development issues into the fewest possible meetings.
- Sponsors should submit meeting packages for all meeting formats, including WRO, within the timelines described in PDFUA and BsUFA agreements. FDA grants and schedules meetings expecting that appropriate information to support the discussion will be submitted with sufficient time for review and preparatory discussion. Thus, the meeting or WRO may be cancelled if the meeting packages are not received within the specified timelines.
- Sponsors should submit a limited number of clearly worded and targeted questions that directly address concerns about the drug and development program. The number of questions in a meeting package should not exceed what can be reasonably discussed within the duration of allotted meeting time.
- Sponsors should provide sufficient data to support the questions being asked. If the meeting package is determined to be inadequate or too voluminous, the meeting may be rescheduled.
- Sponsors’ meeting packages should be well-organized and tabbed to enhance the readability of the background information both before and during the meeting.
- FDA project managers should send preliminary responses to sponsor questions before the meeting so that the meeting time can be dedicated to unresolved issues for which more discussion is needed. In the preliminary responses, FDA should provide high-level recommendations for important issues identified during the review of the meeting package, even if questions concerning those issues were not explicitly posed by the sponsor.
- Sponsor presentations generally are not needed because the information necessary for review and discussion should have been included in the meeting package. Instead, valuable meeting time should be preserved for a focused discussion of issues identified in the meeting package, particularly those that are still unresolved after FDA’s preliminary responses have been sent to the sponsor or that have been raised in FDA’s responses.
- Meeting facilitators should keep the discussion focused on the questions posed by the sponsor in the meeting package, as well as relevant FDA preliminary responses, taking into account the total time available for discussion of the questions. During the course of the meeting, sponsors should generally not ask substantive questions that were not included in the meeting package, or present new data or information that was not previously provided to FDA or requested by FDA in their preliminary comments. Such questions and presentation of new data generally are best addressed in a subsequent communication or meeting request to FDA.
- Pre-IND and pre-NDA/BLA meetings should include a discussion of what constitutes a complete application to ensure there is mutual understanding and agreement on the contents of a complete application.
- Sponsors and/or FDA attendees should summarize important discussion points, agreements, clarifications, and actions items either at the end of the meeting or after the discussion of each question. It is helpful for the sponsor to provide an overall summary of the discussion at the end of the meeting to ensure that there is mutual understanding of meeting outcomes and action items.
- FDA minutes of meetings with IND sponsors are not intended to represent a transcript of the meeting but rather are intended to summarize the important elements of the discussion while also identifying any agreements, disagreements, and action items that were identified during the meeting.
- FDA project managers will use established meeting minutes templates to ensure that all important meeting information is captured.
- FDA project managers will issue meeting minutes, or provide responses to WRO requests, according to the timelines described in PDUFA and BsUFA agreements.
- If there is a significant difference in the sponsor’s and FDA’s understanding of the content of the meeting minutes, sponsors should seek resolution by notifying FDA of their understanding of the discrepancy.
As stated in the FDA’s draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.”