Studies using an investigational drug (not FDA-approved) in a clinical study are regulated by the Food and Drug Administration (FDA). Additionally, some studies testing FDA-approved drugs when used in and investigational way (“off-label”, new patient population, new dosage, new route of administration, etc.) are also regulated by the FDA. Specific requirements regarding the development, manufacturing, documentation, as well as other specific requirements may be needed to comply with the FDA regulations and law. Therefore, we offer support to Georgia Tech faculty, students, and staff in complying with all applicable regulations and laws. Please see the FAQs below for more detail.
