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.