Audio Transcript

We recommend that you send your meeting request via Fed-Ex or UPS directly to the appropriate Office, that is ONP or OND. The contact information for each review Division is available in the Resources tab of this module.

You can also fax your request to the appropriate Project Manager. If you email or fax the meeting request, please arrange for confirmation of receipt prior to sending.

You will be contacted by someone from the appropriate office once your meeting request is received to discuss the purpose of the meeting and to set up a meeting time, if the meeting is granted. You will receive a letter notifying you of the Pre-IND number and the meeting date. The letter will also contain additional information regarding the meeting and meeting package. You will need to send the meeting information packages to the document room; address information for the document room is available in the Resources tab of this module.

Pre-IND meetings, if granted, are considered Type B meetings by the FDA. Type B meetings are scheduled within 60 days of receipt of the meeting request. Depending on availability of staff and the requestor's schedule, however, some meetings occur beyond the 60 days timeframe, but only at a time agreed upon by both parties. The FDA will issue minutes of the meeting to the requestor as the official record of the discussion and agreements from the meeting within 30 days after the meeting.

Depending on the stage of your drug development program, the information that you can provide and the questions that you have, it may be determined that it would be more appropriate for you to have a general Guidance meeting with us. These types of meetings, referred to as Type C meetings, are scheduled within 75 days of receipt of the meeting request. Again, depending on availability of staff and the requestor's schedule, sometimes meetings occur beyond the 75 days, but only at a time that is agreed upon by both parties.