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.

The Fundamental research exclusion is a broad-based general legal exclusion to protect technical information (but not tangible items) involved in research from being controlled by export controls. In other words, research qualifying as “fundamental research” is not subject to export controls.

The public domain exclusion applies to information that is published and that is generally accessible or available to the public through:

The educational information exclusion covers commonly taught in courses listed in catalogues and associated teaching laboratories of academic institutions in the United States.

If the U.S. Government funds research and specific controls are agreed on to protect information resulting from the research, then information resulting from the project will not be considered fundamental research. Such controls are usually contained in contractual clauses. Examples of "specific controls" include requirements for prepublication “approval” by the Government; restrictions on dissemination of information to non-U.S. citizens or other categories of persons; or restrictions on participation of non-U.S.