INTERACT meetings are formal meetings held between sponsors of innovative investigational biological products and CBER to obtain early advice from the FDA on chemistry, manufacturing, and controls (CMC), pharmacology/toxicology, and/or clinical aspects of their AAV gene therapy development program. [1]
How is this different from a Pre-IND meeting?
An INTERACT meeting is not intended to take the place of Pre-IND meeting nor is it a prerequisite to requesting a Pre-IND meeting and is considered when early nonbinding feedback would be important to shape investigational plans. Like Pre-IND meetings, they are not a required FDA meeting.
The main difference for the INTERACT meeting is the phase of development and therefore, the types of questions you will be asking the FDA. The INTERACT meeting allows you to obtain preliminary feedback on your investigational product earlier in development than the Pre-IND stage, thus the background content in the request and package affects a much earlier stage of development.
Another difference is that you need to submit your meeting package together with your INTERACT meeting request letter (whereas you can submit together or separately for Pre-IND).