“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.

Yes. The University of Arizona, as outlined in its Export Control Policy, is committed to complying with U.S. export controls laws and regulations that apply to its activities, including the International Traffic in Arms Regulations (ITAR), the Export Administration Regulations (EAR), and the Office of Foreign Assets Control (OFAC) regulations.

Export Control applies for all export control licenses on behalf of the University. NOTE: Obtaining an export license may take several months and there is no guarantee that the U.S. government will approve a license request.

Primary Investigators (PIs) are responsible for:

1. Assisting Export Control in the identification of activities that may intersect with export control regulations;
2. Maintaining a current export control training certification;
3. Confirming with Export Control all project personnel have completed training and are cleared to access export-controlled items;
4. Notifying Export Control of potential violations.

Research is not subject to export controls if it qualifies for at least one of three exclusions:

(1) Fundamental research exclusion;

(2) Public domain exclusion; and

(3) Education Information Exclusion.