by Jamie Kendall and Noah Mallon
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The authors assert that FDA’s vagueness in the December 27, 2011-released Draft Guidance for Responding to Unsolicited Requests for Off-Label Information (“Draft Guidance”) is a cause for alarm by regulated industry. The authors contend that without further clarification from FDA as to what constitutes permissible practices, companies run the risk of unintentionally engaging in what FDA may deem as off-label promotion. This article outlines areas of ambiguity within the Draft Guidance and potential conflict with FDA’s responsibility to further public health through dissemination of off-label information.