Prior to the INTERACT Meeting

For INTERACT meetings, as indicated in the table above, OTP will send the preliminary response no later than 5 days before the scheduled meeting.  The sponsor is expected to respond to OTP’s preliminary responses not later than 3 days prior to the scheduled teleconference (see Table above).

• If the sponsor finds that OTP’s preliminary responses and advice are sufficiently clear and complete to obviate the need for further discussion, the sponsor should inform OTP in writing as soon as possible so that OTP may cancel the meeting. These responses would then become the official OTP responses to the sponsor’s questions.
  • If, after cancellation of the INTERACT meeting, the sponsor subsequently wishes to follow-up on topics from the preliminary responses or pose new questions, then the sponsor should submit these follow-up or new questions in their Pre-IND meeting. 
• If the sponsor wishes to continue with the meeting, the sponsor should identify which of the original questions in the briefing package they wish to discuss and list the questions in the proposed order of discussion. As a rule, the meeting discussion follows the prioritized order of importance set by the sponsor, with the understanding that all questions may not be addressed due to time constraints.   When referencing questions, the sponsor should use OTP’s preliminary responses document numbering format.
• After receiving OTP’s preliminary response, the sponsor should not submit new questions and new information (e.g., alternative approaches or new proposals to address OTP comments) that were not previously submitted in the original briefing package. OTP preliminary responses are prepared after deliberative review, and usually include cross discipline internal discussion of the original meeting package and questions.  OTP will not have adequate time to review new material and have sufficient inter-discipline internal discussion necessary to prepare answers to new questions.  Therefore, sponsors should thoughtfully prepare their meeting package and questions.
  • In some situations, a sponsor may want to develop new questions/alternative approaches in response to OTP’s preliminary responses or discussion at the meeting.  Such new questions/alternative approaches should be submitted as part of the Pre-IND meeting package.

During the INTERACT Meeting

The meeting is the sponsor’s opportunity to obtain clarifications on OTP preliminary responses. As stated above, during the meeting the OTP team will not be able to provide feedback on new information (e.g., new questions, alternative approaches or new proposals to address OTP comments) that was not previously submitted in the original briefing package.

Sponsors may choose to make a presentation at the beginning of the meeting.  However, because OTP staff will be familiar with the meeting package content and questions, OTP recommends that sponsors forgo a presentation and use the allotted meeting time to obtain clarifications to OTP’s preliminary responses to the sponsor’s questions. 

OTP recommends that time be reserved at the end of the meeting for the sponsor to summarize the major discussion points and action items.

After the INTERACT Meeting

OTP will NOT issue a meeting summary after the meeting.  For INTERACT meetings, preliminary responses will be annotated and resent within 30 days if advice provided changes as a result of the meeting. 

Request for Clarification

A request for clarification may be sought after an INTERACT meeting, to ensure the requestor’s understanding of FDA feedback provided in a preliminary response (if the formal meeting was canceled) or written response issued by FDA.

Find out more about Requests for Clarification