Support for research teams navigating the investigational new drug approval process

Clinical Trials for drugs being developed for initial use in humans as well as for FDA approved drugs but being investigated for additional use(s) require an Investigational New Drug Approval (IND) from the FDA prior to commencing.

For clinical trials involving marketed drug(s) for alternative use an IND Exemption may be an acceptable alternative. The CCTS, in collaboration with the OSU Drug Development Institute and Nationwide Children’s Hospital’s Drug and Device Development Services, can help research teams navigate these potentially complex processes.