The U.S. Food and Drug Administration (FDA) recently released a podcast on biosimilars, featuring Dr. Sarah Yim, director of FDA’s Office of Therapeutic Biologics and Biosimilars (OTBB), that seems to indicate a potential...more
Enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (21 USC 355-2) addresses concerns that some brand...more