5 Takeaways From FDA's Off-Label Promotion Guidance

Law360, New York (March 5, 2014, 4:12 PM EST) -- New guidance from the U.S. Food and Drug Administration clarifies how drugmakers and device makers can avoid illicit off-label marketing when sharing scientific literature about unapproved uses of their products, scrubbing away a few more gray areas surrounding enforcement practices that carry multibillion-dollar implications. 

The FDA’s attempt to tie up loose ends comes at a tumultuous time for off-label promotion, which continues to factor into massive False Claims Act settlements while also being increasingly viewed as protected speech in some circumstances.

Here are five takeaways lawyers...
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