On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and exclusivity-related information for approved drugs listed...more
On July 18, FDA Commissioner Scott Gottlieb, M.D., announced the release of FDA’s Biosimilars Action Plan (BAP), saying it would help enable a path to competition for biologics from biosimilars, while preserving incentives...more