The Orange Book Transparency Act of 2020, signed into law on January 5, amends section 505(j) of the Federal Food, Drug and Cosmetic Act, codifying and clarifying some patent listing requirements of existing FDA regulations....more
Signed into law on December 27, 2020, the Biological Product Patent Transparency Act (42 U.S.C. § 262(k)(9)) requires biological reference product sponsors to provide to the US Food and Drug Administration within 30 days of...more