Good Clinical Practice Q&As

摘要

If you are a healthcare provider and you prescribe a marketed drug to treat an individual patient for an unlabeled indication (also referred to as “off-label use”), an IND is not required because this use is considered to be within the scope of medical practice and not a clinical investigation. However, if you use the marketed drug for the same purpose in a clinical investigation intended to evaluate the drug’s ability to treat a disease or condition, an IND is required under Part 312, unless the clinical investigation meets the criteria for an exemption for studies of lawfully marketed drugs.