FDA OKs Journal Articles Promoting Off-Label Uses

Law360, New York (January 12, 2009, 12:00 AM EST) -- The U.S. Food and Drug Administration has finalized controversial guidelines that allow drug and device manufacturers to use medical journal articles to promote unapproved uses for their products.

The guidelines, dated Thursday, allow drugmakers to disseminate medical or scientific journal articles and reference publications that discuss unapproved uses of drugs, biologics and medical devices that are FDA-approved.

The FDA distributed a draft of the guidance, which is titled “Good Reprint Practices for the Distribution of Medicinal Journal Articles and Medical or Scientific Reference Publications on Unapproved...
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