Frequently Asked Questions
Do I need an investigational new drug (IND) application to study an FDA approved drug?
12/12/2022
Yes. UNLESS your study meets ALL of the IND exemption criteria at 21 CFR 312.2(b)(1).
Note that only lawfully marketed drugs are eligible for an IND exemption. For example, a supplement is marketed as a dietary supplement, not as a drug; therefore, an IND application to FDA would be required to study the safety and effectiveness of a supplement to treat disease.
The final decision regarding whether you are required to obtain an IND may be made only by the FDA or an IRB.
