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 ?
0 mg) and off-label use of additional GLP-1 receptor agonists are expected to contribute over $1 billion in 2024 sales to the obesity market, with SGLT-2 inhibitors making more modest (refer to Pharmacor: Obesity report for more detail).
The government's off-label promotion theory is improperly content-based because it disfavors particular messages,' distinguish [ing] between favored speech and disfavored speech on the basis of the ideas or views expressed,'" Root claimed in his mid-August motion to dismiss the indictment.
Opioid-induced constipation can be managed by changing lifestyle along with the use of targeted therapies and other OTC and off-label drugs.
However, it is important that we do not take a lackadaisical attitude toward prescribing off-label medications.
Many legal experts have been concerned for some time that the FDA's schizophrenic stance on off-label speech violates free speech protected by the First Amendment.
There is no case law precedent that directly addresses the off-label use of HGH, yet MQAC embraced a new position that is contrary to the plain language of the federal statute in question (21 USC 333 [e]), as well as its legislative intent, which permits physicians to prescribe HGH for either the treatment of a disease or certain other conditions that are not diseases but are nonetheless expressly authorized by the secretary of the US Department of Health and Human Services.
The complaint further alleged that Medtronic aggressively promoted off-label uses of its device utilizing journal articles, advertising media, sales representatives and consultants and paid leading physicians to urge the use and purchase of Infuse.
event for healthcare and pharmaceutical companies seeking to understand compliance with FDA's off-label regulations.
In December, the 2nd Circuit called into question the legal underpinnings of many such drug misbranding cases when it vacated the conviction of pharmaceutical sales rep Alfred Caronia for off-label but truthful promotion, contending it violated his First Amendment rights.
In other words, is it ok for a doctor to prescribe a drug for an off-label use because the doctor has seen it work for other conditions?
Though off-label drug use can be beneficial and is sometimes necessary, (7) prescribing a drug for a use not approved by the FDA carries certain risks.
Published in the Federal Register on the last business day of 2011, the Draft Guidance has been narrowed to address only unsolicited off-label information requests.