Shortcomings Of Best Practices Report On Drug Labeling

Law360, New York (July 23, 2013, 12:34 PM EDT) -- When it was signed into law by President Obama on July 12, 2012, the Food and Drug Administration Safety Information Act, Pub. L. No. 112-144, 126 Stat. 1055 (2012) (FDASIA) was best known for its five-year reauthorization of brand pharmaceuticals user fees and the creation of a new user-fee program for generic and biosimilar products. However, the FDASIA contains a number of additional provisions, some of which relate to improving patient access to medical treatments and technologies.

Among these is Section 904, which authorizes the Architectural...
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