IND Development Toolkit
This section will 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 information provided in the following links focuses on INDs for studies of marketed medical products for new indications. For additional information on submitting INDs for unmarketed medical products please contact the ITHS Preclinical Research Development team directly.
The toolkit contains templates and guidance relevant to each step in the process. We recommend that you submit your first IND to ITHS for review prior to submission to FDA.