involving 14. Clinical investigations marketed drug products may be exempt from the IND requirements. Which criteria below may not qualify for an exemption? (1 Point) The drug product is lawfully marketed in a foreign country The investigation is conducted in compliance with the requirements for review by an IRB and the requirements for informed consent The drug product is lawfully marketed in the U.S. For prescription drugs, the investigation is not intended to support a significant change in the advertising for the drug