This is the ‘meat’ of the Pre-IND MIP. In this section, your goal is to provide the FDA with a list of the key questions for discussion grouped by discipline (CMC, Pre-clinical, Clinical) and a summary of background and need for each. Since the FDA recommends limiting your questions to less than 12, you should use this opportunity to ask critical questions related to your specific development program; also refer to available FDA guidances applicable to your product.
For maximum efficiency, it is important to pose clear, focused questions, so that the FDA can provide advice targeted to your specific product development program. If questions are too broad or general, the response you get may also be general.
Another thing to keep in mind is that you should refrain from asking single multi-topic, all-encompassing questions such as ‘Are the starting material selection, manufacturing process and analytical testing acceptable?’ Rather, you should ask specific and clear questions like the following directional examples (tailored to your specific product, of course):
Does the FDA agree that the proposed CMC package supports the intended clinical investigation?
Does the FDA agree with the proposed release specifications and testing strategy?
Does the FDA agree with the stability testing of the drug substance and drug product?
Is the assay qualification plan sufficient?
Is the delivery device compatibility plan sufficient [if a device is integral to your product delivery]?