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Proposed Intended-Use Amendments Invite Questions About FDA's Off-Label Intentions

This article was originally published in The Gray Sheet

Executive Summary

The agency issued a proposed rule addressing tobacco regulation last month that also includes amendments regarding "intended uses" of devices and drugs. It could offer an opportunity for companies to get more clarity from FDA on off-label promotion issues. But one attorney says it's frustrating that FDA neglected to incorporate any recent feedback from the courts that its enforcement of off-label marketing runs afoul of the First Amendment.


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