Investigational New Drug (IND)
If the investigational drug does not already have an Investigational New Drug (IND) in effect with the FDA (either obtained by the pharmaceutical sponsor or the investigator of the proposed study), does it meet the FDA’s definition of ‘exempt from IND requirements’? If not, a formal IND submission to the FDA is required.
Any drug that does not currently have FDA approval for marketing requires an IND before it can be administered as a part of a research study, so therefore cannot be exempt from IND requirements. In some cases an FDA-approved (marketed) drug must also be conducted under an IND.
Refer to the FDA’s guidance “Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND, September, 2013”.
For guidance on determining whether an IND is required, or compiling an IND for submission to the FDA, contact the SOM Clinical Trials Office at 434-924-8570 or uvaclinicaltrials@virginia.edu.