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.
Let FDLI do the work for you — Purchase this edition now and avoid spending countless hours trying to piece together the landmark changes to the FDCA. This Statutory Supplement is your handy go-to source for the text of the current FDCA.
This edition includes a complimentary CD with the entire volume in electronic format for greater accessibility.
||Joy J. Liu, Esq.
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