Guide to submitting Investigational New Drug (IND) applications to the FDA
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Investigators who are conducting clinical investigations with human participants using FDA-regulated drugs or biologics may first need to submit an Investigational New Drug (IND) application to the FDA. An IND is commonly required when administering a drug or biologic that has not been approved by the FDA, or when using a drug outside of the FDA approved indications for research purposes. This document will provide information and links that can guide you through the process of applying to the FDA for an IND.
Created by the CCTS and the UIC Office for the Protection of Research Subjects