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Expert Analysis

Arizona's Off-Label Promotion Law May Hinge On Gottlieb

By Alexis Kellert, Weil Gotshal & Manges LLP (May 8, 2017, 3:54 PM EDT) -- In November, the U.S. Food and Drug Administration announced its decision to collect feedback regarding whether drug and device manufacturers should be allowed to promote their products for uses outside of their FDA-approved treatments (i.e., "off-label").[1] The mere fact that the FDA sought this type of public input on the issue marked a significant shift in the agency's enforcement regime, which has prohibited off-label advertising since the mid-1960s....

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