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July 2, 2012

A Reference Guide to the Food and Drug Administration Safety and Innovation Act

Arnold & Porter Advisory

On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA or the Act). In the drug area, the legislation amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand drug supply chain requirements affecting both foreign and domestic facilities. FDASIA requires these facilities to include unique facility identifiers in their establishment registration. The Act will reauthorize the Prescription Drug User Fee Act and the Medical Device User Fee Act, and authorize new user fees via the Generic Drug User Fee Act (GDUFA) and the Biosimilar User Fee Act (BSUFA). Beyond user fees, FDASIA addresses a range of other significant regulatory changes.

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