BioCentury
ARTICLE | Politics & Policy

FDA updating off-label publication guidance

March 4, 2014 1:58 AM UTC

FDA issued draft guidance on recommended practices for how companies can distribute papers, reference texts and clinical guidelines that describe off-label uses of drugs or devices to health care professionals. To distribute journal articles on off-label uses, the draft guidance notes that companies should include the approved labeling and a "representative publication" that "reaches contrary or different conclusions regarding the unapproved use." For reference texts and clinical guidelines, the guidance notes that material should be distributed with the full label, identify the manufacturer, and note that some of the uses in the text or clinical guidelines might not be FDA approved. ...