The FDA allows for one pre-IND meeting prior to IND submission to discuss any questions or concerns concerning clinical trial approach. Any topics may be discussed during this meeting including questions concerning general product development, manufacturing information, nonclinical testing, protocol design or other regulatory questions. Overall, meeting with the FDA has proven to decrease drug development time. There is no fee to the investigator associated with this meeting.
The process for requesting a pre-IND meeting starts by submitting a meeting request letter to the FDA which includes a draft of a brief product description, objectives and expected outcomes, proposed agenda, preliminary questions, sponsor attendees and proposed dates for the meeting. Meetings last up to one hour via an in-person meeting or teleconference. In addition to an in-person meeting, a written response can also be requested. The FDA will respond with the meeting date and the type of meeting granted. The study team will then need to send a briefing package 30 days prior to the meeting with finalized questions and information. The FDA will respond to your briefing package about 24 hours before the meeting, providing you time to review their responses prior to your discussion with them. If their written response is sufficient, the meeting can be cancelled. The meeting should be focused on any outstanding questions remaining. No new questions or proposals may be raised during the pre-IND meeting.
