FDA Updates Guidance On Avoiding Off-Label Promotion

Law360, New York (February 28, 2014, 6:35 PM EST) -- Aiming to erase confusion, the U.S. Food and Drug Administration on Friday updated its policies on how drugmakers and medical device manufacturers can distribute scientific studies about unapproved uses of their products without engaging in illicit off-label promotion.

In its revised draft guidance, the FDA stuck to certain basic positions, such as expecting that any shared articles from medical journals will typically have been peer-reviewed and passed along in unabridged form. Similarly, drug and device companies must not falsely suggest that a favorable study represents consensus...
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