If you are granted an INTERACT meeting, congratulations. The OTP will try to inform you in advance if any specific review discipline will not be able to participate (e.g., if any review team is not available due to workload/competing priorities). [1]
In the case of a teleconference, the FDA will send written responses to your questions in the meeting package no later than 1 day before the meeting to facilitate the discussion. Please refer to CHED-INTERACT- Preliminary Responses From FDA for an example of the meeting responses the FDA will provide prior to the meeting. For WRO meetings, the response is provided on the committed date. Please note that no additional questions will be accepted, but if you find the written responses provided by CBER sufficient and not warranting further discussion, you may cancel the meeting. [2]
If managed wisely and well prepared for, the INTERACT meeting can prove important for getting the right early input from the FDA. Below are some guidelines to make the most of a teleconference INTERACT meeting.
DO's | DON'Ts |
|---|---|
✅ As your MIP will be relatively limited (compared to Pre-IND), include sufficient detail for questions ✅ Highlight most important questions for discussion that have no substantive references or have not been addressed by any initial FDA feedback ✅ Take advantage of the INTERACT meeting setting to get early advice ✅ Summarize important points, agreements, clarifications, and action items to take into Pre-IND preparation ✅ Listen closely, be objective, and have your team also take excellent notes as official meeting minutes are not issued | ❌ Approach the INTERACT meeting process when you are too advanced or premature – consider the alternatives ❌ Be discouraged by a F2F meeting denial – you can still get valuable FDA feedback from the written response ❌ Be overwhelmingly detailed or include new material or questions that were not part of the MIP– FDA may not be able to provide commentary in this setting ❌ Attempt to answer every question from the MIP – time will be limited so organize questions in order of priority ❌ Hide any concerns. Open dialogue is the purpose of this early interaction |