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2 Detailed Guides To The New FDA Safety & Innovation Act (FDASIA) – Implementation Impacts

July 24, 2012

         The FDA Safety and Innovation Act (FDASIA) is signed on July 9, 2012, by President Obama, as reported in the Orphan Druganaut July 11, 2012 Blog Post.

        An excellent 20-page document in the Pharmaceutical Law & Industry Report (Vol. 10, NO. 29) titled, “A Guide to the Food and Drug Administration Safety and Innovation Act”, is published on July 20, 2012, and is a great guide to its implementations and impacts on the following : 

         – Rare diseases

         – Orphan drugs

         – Rare pediatric disease priority review voucher incentive program

         – “Breakthrough therapies”

         – Consultation with rare disease medical experts

         – Acceleration of new medical treatments for patient access. 

        Another excellent resource is the very detailed 52-page July 20, 2012, document from the Law Firm, Arnold & Porter LLP, titled,“ A Reference Guide to the Food & Drug Administration Safety and Innovation Act”.

         Happy Reading ……

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