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Do I need an investigational new drug (IND) application to study an FDA approved drug?

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.