Definitions for "OFF-LABEL USE"
The use of a drug for a purpose, or at a dose, other than that approved by the FDA Office for Human Research Protection (OHRP): U.S. government agency that issues Assurances and overseas compliance of regulatory guidelines by research institutions
Prescription of a medication outside its approved indication or prescription of a drug in a deviated dose other than recommended by the authorities.
Use of a drug for a disease or condition other than the specific disease or condition for which the FDA approved it.
Operational Qualification (OQ) OQ