off label

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off label

adj, adv (off-label when prenominal)

(Medicine) (of a prescription drug) relating to use, or being used, in ways for which it has not been approved

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References in periodicals archive ?

Even if a drug is legal and prescribing it for off-label use is legal, it is "misbranding" for the drug maker to share accurate information about the off-label use.

Protecting free speech in medicine: why shouldn't drug makers have the right to distribute accurate information?

However, direct regulation of off-label use raises its own constitutional concerns.

Off-label drug marketing, the First Amendment, and federalism

The court noted that prohibiting this type of speech "interferes with the ability of physicians and patients to receive potentially relevant treatment information; such barriers to information about off-label use could inhibit, to the public's detriment, informed and intelligent treatment decisions.

The 'structure-function' dysfunction

As the National Cancer Institute states, "Often, usual care for a specific type or stage of cancer includes the off-label use of one or more drugs.

Off-label on the table

First, we propose a more thoroughgoing reporting of off-label use (via the disclosure of diagnostic codes and "detailing" data) in manufacturers' annual reports to the FDA, in the adverse event reports to the FDA, in Medicare/Medicaid reimbursement requests, and, for a subset of FDA-designated drugs, in prescriptions themselves.

Evidence and extrapolation: mechanisms for regulating off-label uses of drugs and devices

for speech promoting the lawful, off-label use of an FDA-approved drug.

Off-label marketing of pharmaceutical products in the wake of United States v. Caronia and United States v. Harkonen

The Second Circuit concluded that "the government clearly prosecuted Caronia for his words--for his speech" and "slapped down [the] FDA's and DoJ's long-standing contention that the Food, Drug & Cosmetic Act (FDCA) makes it illegal for drug companies and their employees to communicate about an off-label use.

US food and drug administration--approved laboratory tests after Caronia

Off-label use of Infuse by physicians constituted nearly 90 percent of the $800 million in revenue that Infuse generated for Medtronic in 2011.

Court rejects Medtronic's plea to throw out lawsuit

Psychiatrists must rely on multiple, sometimes-conflicting sources to determine whether evidence is sufficient to support off-label use in a specific clinical scenario.

When is off-label prescribing appropriate? After evaluating all available evidence, carefully consider your patient's individual risks

Examples of public unsolicited requests include scenarios in which an individual asks a question regarding an off-label use during a live presentation or posts a question about an offlabel use on either a firm-controlled website or a third-party discussion forum that is visible to a broader audience.

Off-label and pre-approval promotion: new guidance seeks to clear up manufacturer communications

Other activities that could lead to 'solicited' requests about off-label use include

Walking the social media tightrope

Off-label use of the novel therapeutic prostate cancer vaccine, marketed by Dendreon under the trade name Provenge, would be left to the discretion of local Medicare claims carriers, the agency said.