The purpose of the OFAC regulations is to enforce embargoes and economic sanctions. In general, the OFAC regulations prohibit exports to certain sanctioned/embargoed countries such as Iran, Cuba, Sudan, North Korea, and Syria.

Sanctioned Countries are designated by the U.S. Government as having limited or comprehensive trade sanctions and embargoes imposed for reasons of anti-terrorism, non-proliferation, narcotics trafficking, or other reasons. Sanctions are prohibitions on transactions (e.g., financial exchanges, providing or receiving services of value) with designated countries, entities, or individuals.

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.