FDA recently doubled down on its approach of allowing new language in an ANDA label as the result of a section viii statement – a so-called “carve-in.” Section viii statements assert that an ANDA does not seek approval for...more
When the Federal Circuit resurrected Amarin’s “skinny label” infringement claims against Hikma last month, it offered some important lessons for drug developers. The precedential decision helps clarify the kinds of...more
1 Last week, the Food and Drug Law Institute held its Annual Conference while also celebrating its 75th anniversary. There, members of FDA and industry players gathered to discuss the latest legal, policy, and regulatory...more