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Major lobby groups representing diagnostic test makers wrote to House and Senate committee heads on Monday (May 6) asking them to work with stakeholders and FDA to revise their draft legislation that lays out an approach for FDA to regulate in-vitro clinical tests. The groups have different views on FDA’s purview, but they generally agree that diagnostic tests should be regulated differently than traditional medical devices. ML Strategies Senior Director Aaron Josephson talks about this latest draft of the bill.
Alden Bianchi, Chair of Mintz’s Employee Benefits & Executive Compensation Practice contributed this column discussing how it’s too soon to tell whether the decision in New York v. DOL is a battle in a larger war or the war itself.

Member Laurence Freedman provides analysis on recent development, legal questions raised thus far, and what’s at stake in the Supreme Court's recent interest in the Intermountain Healthcare Inc. FCA case.
Amazon has a new idea for settling patent disputes — one that doesn’t involve courtrooms, judges or expensive trials. Here, Michael Graif comments on the pilot program that allows patent owners to confront merchants they believe are selling infringing products on the platform.
Given the many substantive and strategic lessons to be learned from FCA investigations and litigations, bankruptcy counsel advising the various constituents impacted by an FCA case should be mindful of these potential lessons, as they may raise issues relevant to the bankruptcy estate, says Health Law attorney Samantha Kingsbury in this article.
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