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FDA Safety And Innovation Act (FDASIA): The Importance Of And Impact On Orphan Drug Development

October 29, 2012

       The FDA Safety & Innovation Act (S. 3187) is enacted after President Obama signs it on July 9, 2012. As noted in a previous Orphan Druganaut Blog Post, FDASIA “is a big step towards the development of effective and safe treatments for rare diseases and orphan drug development in the United States.” 

        Because of its importance and impact on future orphan drug development, the Orphan Druganaut Blog has decided to provide another Blog Post. The 2 previous blog posts are provided (in the References section below) so that one can link for further information. 

        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”.


Orphan Druganaut August 24, 2012 Blog Post titled, “Food and Drug Administration Safety and Innovation Act (FDASIA) And Orphan Drugs: A New Perspective” 

Orphan Druganaut July 11, 2012 Blog Post titled, “New FDA Safety & Innovation Act Impact on Orphan Drugs ?”. 

Copyright  © 2012-2013, Ann-Teresa Cusenza and Orphan Druganaut Blog.  All rights reserved.

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