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FDCA

242 published works

  1. Drug & Device Law

    Regulatory Compliance and Punitive Damages

    By Bexis

    We’ve already posted a number of items about Philip Morris USA v. Williams, 127 S.Ct. 1057 (2007), but like a kids in a candy store, we’re still looking at the…

  2. Drug & Device Law

    Defenses to FDCA-Based Negligence Per Se

    By Bexis

    In this post we discuss something that most definitely is not near and dear to our hearts. In fact it’s just the opposite. We hate it. And if you defend…