ISPE Glossary of Pharmaceutical and Biotechnology Terminology

Print this page         
Find Definition by Term and/or Language
Term Language (Optional)
Browse All Terms
Beginning With By Language
A B C D E F G H I J K L M N O P Q R S T U V W X Y Z :: All English

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

Do you have a term that should be included in the glossary?
Submit a term for review


  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile
Click to go to the Member Gift