Off-label definition
Off-label means the prescribed use of a drug which is other than that stated in its FDA approved labeling.
Off-label means the use of a drug for clinical indications other than those stated in the labeling approved by the federal food and drug administration.
Off-label means use of Products in a manner which is not consistent with the product indication cleared by the USFDA.
Examples of Off-label in a sentence
Laws §§ 27-55-1 and 27-55-2, Off-Label Uses for Prescription Drugs.
Purchaser will immediately notify Moderna in the event that Purchaser becomes aware that any Product has been packaged, administered or used other than in accordance with the Marketing Approval for the Product in the Territory, including for any Off-Label Use.
More Definitions of Off-label
Off-label means the use of an United States Food and Drug Administration-approved drug, biological product, or device other than the use(s) approved by the FDA.
Off-label means the use of a drug for clinical indications other than those stated in the labeling approved by the United States Food and Drug Administration.
Off-label means a use, including indication, dosage, population, and/or method of administration, not consistent with the use approved by the FDA in the Labeling for a Covered Product at the time information regarding such use was communicated, or at the time the conduct occurred.
Off-label means any promotion inconsistent with a Vapotherm product’s applicable clearance or authorization documentation and the product’s instructions for use.
Off-label means a use (including indication, dosage, population, and/or method of administration) not consistent with the use approved by the FDA in the Labeling for
Off-label means the use of a drug for clinical indications other than those stated in the labeling approved by the FDA.
Off-label use means use of an AgVet chemical contrary to the instructions provided on the product label – i.e. in a manner other than that authorised by regulation.