An academic researcher may be required to submit an IND application to FDA in order to study a marketed medical product in a new (i.e. unapproved) clinical indication. An investigator is always required to hold an IND to study an unmarketed (i.e. unapproved) medical product. In both cases, the products are considered “investigational” by FDA. The vast majority of INDs on file with the FDA are for noncommercial research.
This website aims to help faculty navigate the process of developing a Sponsor-Investigator IND. The following article from the Journal of Investigative Medicine provides an overview: Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators (Holbein, M. E. Blair, Journal of Investigative Medicine. 57(6):688-694, August 2009). The FDA has also published a guidance on determining the applicability of IND regulations on your clinical program (Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND).The information provided in the following links focuses primarily on INDs for studies of marketed medical products for new indications. For additional information on submitting INDs for unmarketed, novel medical products please contact VCTRS.
The left menu is a step-by-step toolkit aiming to provide relevant links for templates and guidance for each step. We recommend that you submit your initial IND to VCTRS for review prior to submission to FDA.