Communications before the meeting b

Communications before the meeting between requesters and the FDA, including preliminary responses, can serve as a foundation for discussion or as the final meeting responses. Nevertheless, preliminary responses should not be construed as final unless there is agreement between the requester and the FDA that additional discussion is not necessary for any question (i.e., when the meeting is canceled because the requester is satisfied with the FDA’s preliminary responses), or a particular question is considered resolved allowing extra time for discussion of the more complex questions during the meeting. Preliminary responses communicated by the FDA are not intended to generate the submission of new information or new questions. If a requester nonetheless provides new data or a revised or new proposal, the FDA may not be able to provide comments on the new information or it may necessitate the submission of a new meeting request by the requester.The FDA holds an internal meeting to discuss the content of meeting packages and to gain internal alignment on the preliminary responses. The FDA will send the requester its preliminary responses to the questions in the meeting package no later than 5 calendar days before the meeting date for Type B (EOP) and Type C meetings. The requester will notify the FDA no later than 3 calendar days following receipt of the FDA’s preliminary responses for these meeting types of whether the meeting is still needed, and if it is, the requester will send the FDA a revised meeting agenda indicating which questions the requestor considers as resolved, and which questions the requestor will want to further discuss.[10] For all other meeting types, the FDA intends to send the requester its preliminary responses no later than 2 calendar days before the meeting.