The FDA has a Pre-Investigational New Drug Application (Pre-IND) Consultation Program available to potential IND holders to facilitate early communications regarding an IND. The program allows the sponsor-investigator the opportunity to discuss the proposed project and receive guidance directly from the FDA prior to submitting an IND. The Pre-IND meeting requests are submitted directly to the responsible review division which are organized generally along therapeutic class.
If you think a pre-IND meeting is warranted please contact the SOM Clinical Trials Office at 434-924-8570 or firstname.lastname@example.org. Templates for required documents are available.