ISPE Glossary of Pharmaceutical and Biotechnology Terminology

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Off-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. Any use, other than the FDA approved use (as stated on the labeling), is considered off-label use.

Publication Source: Committees on Human Research

See also: On-Line

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