Aggressive policies that target the use and promotion of off-label use are needed to prevent the use of drugs for non-approved indications with little benefit or with harmful outcomes. It should be ...

Kids ages five to 11 can now be vaccinated against COVID-19 following the Food and Drug Administration's emergency use authorization of the Pfizer Bio-NTech vaccine for this age group and the Centers ...

The off-label use of medicines is not illegal and it doesn’t mean regulators have specifically “disapproved” its use. But there are a number of issues to consider before using a medicine off-label.

When you shop through retailer links on our site, we may earn affiliate commissions. 100% of the fees we collect are used to support our nonprofit mission. Learn more. Nervous about giving a big ...

Cheered by victories in off-label marketing lawsuits, pharma companies were expecting some loosening of the regulatory shackles when the FDA rolled out a new rule on the subject. But that rule, ...

Severe legal penalties await companies that promote the use of their medical devices for procedures unapproved by FDA. Federal law prohibits such off-label promotion, but the practice occurs ...

When your doctor hands you a prescription, you probably assume that the drug was approved to treat the problem you came in for. But that's not always the case. Lots of drugs are prescribed off-label, ...

In a recent national survey, a substantial minority of physicians erroneously believed that certain off-label uses of prescription drugs were approved by the Food and Drug Administration. This ...

Off-label prescribing, which is broadly defined as the prescribing of drugs outside of the marketing authorization determined by a licensing body such as the US Food and Drug Administration, is a ...

Has your doctor ever prescribed an antidepressant to curb your hot flashes or a blood-pressure pill to calm your stage fright? How about an antipsychotic drug to help you sleep? Like most Americans, ...