As of the date of this playbook, INTERACT Meetings are requested via email with the request and meeting information package (MIP) submitted to: cberdcc_emailsub@fda.hhs.gov, with OTPRPMS@fda.hhs.gov in cc line for Regulatory Management Staff awareness. [1]
The OTP will send an acknowledgment email following receipt of request, followed by a decision to grant or deny the meeting through email communication. If you are granted a meeting, it will generally be scheduled within approximately 21 calendar days of request receipt, or reasons for denial will be sent also by Day 21. The meeting will be held via teleconference within approximately 75 calendar days of the request receipt and will usually be 1 hour in duration (see figure for timeline). [2]
Now that you know what to expect with the meeting request process, let’s get into the guidelines for the meeting package which you need to prepare before requesting an INTERACT meeting.