ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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On-Label Uses

Many drugs/devices that have gained FDA approval have uses other than those for which the drug/device was officially evaluated and approved. Once a drug/device has been approved for some use, however, it can be legally prescribed for any use. On-label use is the use of the strict use of a drug/device for only the purposes for which it was approved by the FDA (as reflected on the labeling).

Publication Source: Committees on Human Research

See also: Off-Label

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