Once you have sent the MIP, it is time to prepare for conducting the actual meeting itself. The FDA will send you written comments back, usually 2 days before the planned meeting. This time is an intensive stage as you review and carefully digest the FDA’s comments. During this time, you will also need to work on prioritizing which questions you will discuss in the meeting itself and communicating this to the FDA, as well as finalizing any preparations for presentation. Sometimes the FDA’s written comments are sufficient enough that you can decide to cancel the teleconference meeting.
It is critical to keep in mind that the purpose of the Pre-IND meeting is to have a dialogue with the FDA. Therefore, there is no need to prepare for a long presentation of the MIP – the Pre-IND meeting is usually no longer than 1 hour, so it is crucial to use the time wisely and as effectively as possible. In fact, any presentation by you, the requester, is generally deemed unnecessary because all information for review and discussion should be part of the MIP, and attendees are assumed to have digested it in advance. The meeting will be chaired by an FDA staff member, so you can expect the meeting to be “driven” by them.
Generally, you will be asked to present a summary of your application to ensure that there is mutual understanding of meeting outcomes and action items. This is a good place to reiterate your objectives and concerns/challenges that you require their input on. The FDA staff can then add or further clarify any important points not covered and these items can be added to the meeting minutes.
Here are some guidelines for conducting an effective Pre-IND meeting:
DO’s | DON’Ts |
|---|---|
✅ Discuss with the FDA project manager ahead of time how you wish to prioritize the meeting agenda ✅ Keep any presentation brief to maximize time for discussion ✅ Ensure attendees have slide materials ahead of the meeting ✅ Summarize important points, agreements, clarifications, and action items (this can be done by you or the FDA chair, and at the end of the meeting or after each question ✅ Focus on questions that have not been addressed by any initial FDA feedback ✅ Listen closely, be objective, and have your team also take excellent notes (don’t rely solely on the FDA minutes). | X Record the meeting discussion – this is prohibited, as meeting minutes will be provided by the FDA X Increase the length of a meeting to accommodate a presentation X Include new material or questions that were not part of the MIP– the FDA may not be able to provide commentary, thus defeating the purpose of the meeting X Attempt to answer every question from the MIP – time will be limited so organize questions in order of priority. Stay focused on the agenda X Hide any concerns. Transparency is key X Be defensive or antagonistic especially upon disagreements with the FDA – any misunderstandings or additional input needed can be resolved in the follow-up |