The meeting package should contain summary information pertinent to the product, along with any additional details necessary for formulating responses to issues raised by the requester or the review division. It's essential that all content within the meeting package aligns with the intended meeting objectives. The content will vary based on factors such as the product, its indication, the stage of product development, and the issues to be discussed. When planning and preparing the meeting package, FDA and ICH guidances, which address many aspects of product development, should be taken into account. If the product development plan diverges from existing guidances or standard practices, this deviation should be acknowledged and explained. Any known challenging design and evidence issues, like the use of a surrogate endpoint, reliance on a single study, noninferiority designs, or adaptive designs, should be brought up for discussion. Additionally, simply stating that a result is significant does not provide the review division with sufficient information to offer sound advice or identify critical issues that the requester might have overlooked.

Read the full guidance on Pre-IND meetings.