FDA proposes reprint practice guidance for unapproved uses of drugs and medical devices

February 20, 2008

The Food & Drug Administration proposes guidance for off-label use information.

The Food & Drug Administration has issued a Section 401 of the FDA Modernization Act, which previously set standards for dissemination of such information. The new document recommends principles for manufacturers to follow, including ensuring that an article is published by an organization with an editorial board and that no conflicts of interest exist with authors, contributors, or editors associated with the journal. Articles should also be peer-reviewed. The new draft is against distribution of special supplements or publications that have been sponsored by manufacturers of any of the products discussed in the article. The FDA will retain legal authority to determine whether or not an article is appropriate. Public comments on the draft will be accepted for 60 days and can be submitted to the Division of Dockets Management (HFA-305) at FDA. For single copies of the new draft guidance, call 1-(301)-827-3360.

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