off-label


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off-label

(of-lā'bĕl),
Use of a licensed drug for an indication not approved by the F.D.A. or other governmental regulatory body.

off-label

(ôf′lā′bəl, ŏf′-)
adj.
Of or relating to a drug prescribed to treat a condition for which it has not been approved by the Food and Drug Administration.

Off-label

Referring to the use of a drug for a condition or disorder not listed in the official FDA labeling.
References in periodicals archive ?
Instead, it resorted to a legal technicality: rather than prosecuting off-label advertising outright, it would use off-label speech as evidence of misbranding, a maneuver that supposedly would not violate the First Amendment.
If a manufacturer attempts to recommend usage or disseminate information that has not been approved by the FDA, such "off-label" promotion is considered misbranding, and has regularly met with heavy fines and other penalties.
Off-label prescribing has gained popularity as the process of obtaining modifications to a product license of an existing drug is lengthy and costly.
Although clinicians may cite guidelines that support off-label use of gabapentinoids for pain, the investigators warned that many of these recommendations stand on shaky ground.
Off-label use under CLIA '88 requires providers to restrict the use of these devices to CLIA-waived operators.
A "Off-label" drugs are drugs prescribed for a purpose other than those for which they are approved by the Food and Drug Administration (FDA).
"Developmentally, [children] may be unable to verbally express the side effects they are feeling and may therefore be subject to a drug to treat a drug side effect, especially if their reaction to it is behavioral." There is also potential for unanticipated drug interactions between off-label medications prescribed for sleep and drugs prescribed to treat ADHD.
The NWHN supports clinicians' right to prescribe products off-label for a different population, dosage, or use outside of FDA guidelines, giving them freedom to fine-tune treatments to patients' needs or adjust to research advances that have overtaken regulation.
While controversy exists on the use of drugs for off-label therapies related to prescribing practices, increased adverse events, and lack of supporting evidence for off-label prescribing, the U.S.
It's also been the law for decades that FDA doesn't regulate the practice of medicine, and that once a drug's approved for one use and lawfully on the market, doctors can decide to prescribe it "off-label" for anything they want.
Problem Statement: To date, there have been insufficient studies published concerning the knowledge, attitudes and practices of dental hygienists regarding polypharmacy and off-label drug recognition and use.