Pro Te: Solutio Vol. 8 No. 2

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Summer is in full swing and certain topics are (staying) hot—especially regulatory issues, from new proposed rules to challenges to case law to strategic considerations.

Generic preemption remains a hot topic. In Storm Clouds Gather: An FDA Proposal to Eliminate Generic Preemption, we explore the FDA’s proposed rule that is designed to address challenges related to product safety labeling. Given the FDA’s plan to have a new rule finalized by September 2015, we offer an early look at what the rule could be and its potential impact.

Please see full Newsletter below for more information.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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