FDLI

This new 2012 edition is fully updated to reflect the recent amendments to the Federal Food, Drug, and Cosmetic Act by the Food and Drug Administration Safety and Innovation Act (FDASIA). Signed into law by President Obama in July 2012, FDASIA includes the Prescription Drug User Fee Act (PDUFA ) V, the Medical Device User Fee Act (MDUFA ) III, the Generic Drug User Fee Act (GDUFA) and the Biosimilars User Fee Act (BsUFA). These amendments are presented in track changes (additions are underlined; deletions are struck-through), making it easy to identify updates and changes to the law. Compilation of FDCA-Related Food and Drug Laws, 2010 includes the latest provisions of statutes related to the omnibus Food, Drug, and Cosmetic Act, including those involving regulation of food and medical products, commerce, enforcement activity and administrative law. For practicing attorneys and academics, this is a one-stop resource for finding FDCA-related statutory provisions.