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 ...

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 ...

Medtech executives charged in two high-profile criminal cases are making the argument that FDA is squelching their free speech. Qmed Staff At the same time that the U.S. Justice Department is ...

Overview: Promoting a drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have ...

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 ...

Should a Hollywood film be made based on the grocery world a memorable tagline could very well become "if you promote it, they will come," as promotions take on more significance to the supermarket ...

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 ...