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 ...

The FDA published a rule last month that would change the definition of "intended use" for drugs and devices—and pharma companies aren't in favor. () Cheered by victories in off-label marketing ...

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 ...

One of the most alarming things about COVID-19 is that there are no FDA-approved drugs to fight it. Instead, doctors have turned to medications such as azithromycin, chloroquine, hydroxychloroquine, ...

Using data from the 2012 and 2013 National Ambulatory Medical Care Surveys, researchers looked at all adult outpatient visits to psychiatric practices for chronic care management in which ≥1 ...

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, ...

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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 ...

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 ...