November 7th, 2011
FDA's off-label rule under attack
Los Angeles Times
Prescription drugs and medical devices are frequently used to treat conditions other than those the Food and Drug Administration has specifically approved them for. The main guidance the FDA gives to doctors is to be well informed, have good scientific and medical reasons, and maintain records of any off-label use. The agency bars drug and device manufacturers, however, from promoting their products for more than their approved uses — for example, by giving doctors unsolicited advice about potential off-label applications.
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