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 ...

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 ...

The FDA conducted a public hearing November 9-10 to discuss whether pharmaceutical companies should be allowed to promote drugs for unapproved uses. The FDA also announced that it would fund studies ...

Washington, D.C. – Researchers are asking for tougher penalties and fines for pharmaceutical companies that market drugs for "off label" promotion, according to a study published in the October 28 ...

Merrill Goozner, the author of the author of The $800 Million Pill: The Truth Behind the Cost of New Drugs, questions the assumption that a greater push toward compliance has reduced off-label drug ...

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 ...

Please provide your email address to receive an email when new articles are posted on . A recent ruling in the U.S. Court of Appeals for the Second Circuit may have monumental implications for both ...

Compendia are compilations of drug information that include both on-label and off-label uses. Medicare, Medicaid, and many other insurers will cover off-label uses of reimbursable drugs included in ...