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www.fdanews.com/articles/131705-certain-trials-may-be-exempt-from-requirements-for-inds

Certain Trials May Be Exempt From Requirements for INDs

November 5, 2010
Not every drug sponsor must apply for an investigational new drug (IND) to conduct human clinical trials, the FDA says in a draft guidance designed to clear up confusion and misperceptions about IND exemptions. Generally, clinical trials of human subjects must be conducted under an IND. However, the agency allows three exemptions: some bioavailability or bioequivalence studies, certain trials involving radioactive drugs for research and trials of FDA-approved drugs that will not support a new indication or significant change to labeling.
Clinical Trials Advisor