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A Voyage of Discovery – FDA & Truthful Off-label Speech

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As developments in the world of off-label promotion continue to unfold, we clearly are on a voyage of discovery and ahead lies the New World.  First, we had the Amarin case suggesting that the dissemination of truthful, non-misleading information about use not approved by the U.S. Food and Drug Administration (“FDA”) might not be a prohibited act.[1]  Now we have the U.S. Department of Justice (“DOJ”) acknowledging in a proposed…

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