Now that you know about meeting requests, it is important for you to ensure that all the content provided in the request and the MIP is up to date, accurate, and supports the intended objectives of the meeting.
So, what should you include in your MIP?
Although the contents of the MIP will vary, they generally include product information, questions for the FDA (grouped by discipline – CMC, Pre-clinical, Clinical), and any specific information that will enable the FDA to respond to your questions.
For additional information, please follow the FDA guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products [7]
Next, let’s dive into each of the different sections of the Pre-IND MIP and review what’s important to cover in each of them as you fill out the template. We have also provided you with a template for the MIP (see below) and an example meeting information package you can find linked here: MSD Pre-IND Meeting - Briefing Package.