Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
The US District Court for the District of Delaware granted in part Teva Pharmaceuticals’ renewed motion for judgment as a matter of law (JMOL), finding that substantial evidence did not support the jury’s finding of induced...more
In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more