The FDA does not have a broad outline or specific list of required studies and/or data needed to review any particular product that is provided to the public since the nonclinical drug development process is product and indication specific. However, the two documents referenced here should be useful starting point towards addressing this topic.
Pre-Investigational New Drug (pre-IND) meetings provide an opportunity to obtain important feedback from FDA on your development program. The process to request these meetings is outlined in the guidance document.
When using these criteria, a medical countermeasure product should be rated at a particular level only after the sponsor has completed all activities listed in that level (e.g., a product is rated at TRL 4 once it completes all of the activities listed in TRL 4
National Center for Disaster Medicine and Public Health announces the launch of HTML learning objects: