Alert: Orange Book Transparency Act Creates Some New Obligations
By EsqSocial Corporation 25/01/21
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. It also requires that the FDA provide a list of exclusivities and a report related to certain types of device-related patents....
By: Cooley LLP