Investigational New Drug (IND) Resources

A study can be deemed IND Exempt if all of the following criteria are met:

• If the study is not designed to support approval of a new indication or a change in label;
• If the study is not intended to support a significant change in the advertising for the product;
• If the study does not involve a route of administration, dosage level or patient population that significantly increases the risks (or decreases the acceptability of risk) associated with the use of the drug;
• The study is conducted in compliance with the IRB and Informed Consent regulations; and
• The study is conducted in compliance with regulations regarding promotion for investigational drugs.

An IND is not needed for studies involving marketed drugs such as:

• Some studies using commercially marketed drugs
• Some studies using in vitro diagnostic biological products (e.g., blood grouping serum, reagent red blood cells, anti-human globulin)
• Studies using drugs in vitro or in laboratory research animals

“Off-label use” is any difference in use, including indication, dose, route of administration, patient populations, and drug formulation from what is approved on the FDA label.

“On-label use” means the drug is being used in the same indication, dose, route of administration, patient populations, and drug formulation. There is no deviation from the approved FDA label. Studies involving the on-label use drug do not require an IND, as long as data will not be used in a marketing application.

Drug labeling refers to all the printed material that accompanies a drug, including the label, the wrapping, and the package insert.

Yes, an IND application is a request to the FDA for authorization to administer an investigational drug (or biologic) to human or a marketed drug in a new indication and/or patient population. However, there are IND Exemptions. Please refer to the section on IND Exemptions for more information.  

An investigational drug is defined as:

• An article that is not approved (for marketing) in the US as a drug.
• An approved drug that is not used according to the approved label (or a new combination of approved drugs).

The term includes drugs (including botanicals, biologicals, and gene therapy, and genetically derived products that meet the definition of a “drug”), and medical devices for human use. The FDA has statutory authority to regulate the development and marketing of these products.