It depends on the country and the item. The U.S. government has export restrictions on certain items. Consult with Export Control to determine if your equipment, materials, data, or software is subject to these restrictions. Export Control will obtain licenses, exceptions or assist with other requirements to facilitate your travels, if required. Traveling with a “clean” laptop is recommended.

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

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.