When Is an IND required

An IND is always required prior to initiation of a clinical study of an investiga-tional new drug in the United States. In addition, an IND is required before initiation of a clinical study of a drug approved for some uses, but to be studied clinically for a new indication or at unapproved doses or if the new clinical study is intended to support promotion of the product. The following examples may be helpful.

A sponsor wants to initiate animal toxicology studies of an investigational new drug in the United States. Is an IND required? An IND is not required, because no studies in humans are proposed at this time. A sponsor has a novel antihypertensive drug with supporting pharmacology, toxicology, and manufacturing information. In order to initiate a single-dose pharmacokinetic study in humans in the United States, an IND must be submitted to the FDA.

A sponsor has a drug that is approved by the FDA for the treatment of hypertension. New clinical studies are planned to evaluate the drug in the treatment of congestive heart failure. An IND is required, since the drug is investigational with respect to its unapproved use in patients with congestive heart failure.

A sponsor has a drug that is approved by the FDA for the treatment of hypertension. The sponsor wants to initiate a new clinical study to compare the drug with a major competing antihypertensive product. Both drugs will be used at doses consistent with the FDA-approved labeling. In this case, an IND is required if it is the sponsor's intent to use this study for promotion of its product.

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