Off-Label Reprint Guidance: “Definitely Improved,” But Will Waxman Fight On?
FDA's finalized guidance on off-label reprints contains small modifications that appear to satisfy free speech critics of the draft version. But it does not offer sufficient change to mollify congressional critics who believe the document is too permissive
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FDA has revised, but not loosened, its 2009 final guidance on good reprint practices for distribution of journal articles on unapproved uses of approved drugs and devices.
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