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 ...

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 ...

A new batch of email and memos from the federal litigation over AstraZeneca's antipsychotic Seroquel detail company executives discussing off-label promotion, the stretching of data to make claims ...

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 ...

Researchers are asking for tougher penalties and fines for pharmaceutical companies that market drugs for "off label" promotion, according to a new study. Researchers describe ways that the ...

New York–based drug giant Pfizer is paying $2.3 billion to settle claims of off-label promotion of four of its drugs, including the cyclooxygenase 2 (COX-2) inhibitor Bextra (valdecoxib), the US ...