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Investigational New Drug Development

Investigational New Drug (IND) Applications for Sponsor-Investigators

IND Development Process Overview

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.

Consulting

Regulatory Consulting & Drug Development

We consult with investigators on the scientific information required to support an Investigational New Drug application to FDA.
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Toolkit

Step-by-Step Toolkit

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.
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FAQ

FAQ

Read frequently asked questions about Drug Studies.
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Cite ITHSThe Institute is supported by grants UL1 TR002319, KL2 TR002317, and TL1 TR002318 from the NIH National Center for Advancing Translational Sciences through the Clinical and Translational Science Awards Program (CTSA).

Please help us continue to support your research by citing our grant number(s) in publications we supported.