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 ...

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 ...

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 ...

The omission of criminal charges for off-label promotion of Serostim is surprising, because the government's earlier plea with Pfizer sent a strong signal that it would criminally charge companies ...

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 ...

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 ...