IND Principles The Content outlines the information needed for a commercially sponsored IND for a new molecular entity.

1 A SPONSOR-INVESTIGATOR who uses, as a research tool, an investigational new drug that is ALREADY SUBJECT TO A MANUFACTURER'S IND or marketing application should FOLLOW THE SAME GENERAL FORMAT. 2 a SPONSOR-INVESTIGATOR who uses an investigational drug NOT SUBJECT TO A MANUFACTURER'S IND or marketing application is ordinarily required to SUBMIT ALL TECHNICAL INFORMATION SUPPORTING THE IND, unless such information may be referenced from the scientific literature.