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 it comes to off-label promotion, FDA and industry have been engaged in a cat-and-mouse game for years. And in March, Congress got involved, too. The House Committee on Oversight and Government ...

The FDA has "finalized" guidelines allowing drug companies to promote drugs for unapproved ("off-label") uses. The guidelines will allow companies to distribute peer-reviewed scientific literature ...

While off-label use is sometimes necessary, it should be undertaken with care and caution due to the uncontrolled experiment to which a patient is being subjected. Valuable off-label uses should be ...

In a continuing shift of enforcement strategy, the U.S. Department of Justice (DOJ) has firmly taken control of off-label use allegations against pharmaceutical, biotechnology, and medical device ...

For prescription drugs, demonstrated benefits define the parameters of acceptable risks. For example, liver toxicity may be acceptable in a drug approved for cancer, but unacceptable in a drug ...