Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
The government’s FCA enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement...more
In Harden Manufacturing Co. v. Pfizer, Inc., 712 F.3d 60 (1st Cir. 2013), one of three cases addressing Pfizer’s off-label marketing of the anticonvulsant drug, Neurontin, the First Circuit vacated the district court’s denial...more