The use of a device for a disease not listed on the label, or for an intended use inconsistent with the product labeling
The FDA has proposed guidelines allowing manufacturers to give physicians reprints of medical journal articles about uses of drugs and medical devices that haven’t won the agency’s approval.
The United States federal government is aggressively pursuing criminal and civil cases against pharmaceutical companies and their employees for promoting off-label uses of prescription drugs.
Once a product is approved, it is very important to make sure that all advertising and promotional materials are consistent with the final product labeling.
Pharmaceutical companies are not allowed to promote a drug for any other purpose without formal FDA approval.
Companies generally aren’t allowed to advertise or market such “off-label” uses, though doctors can prescribe drugs for any condition.
Source: Wikipedia| Wall Street Journal | ComplianceOnline
Posted by abhishekkatiyar 
