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

October 13, 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 3 previous blog posts are provided so that one can link for further information. 

         2 detailed Guides to the new FDASIA are available for reference in the Orphan Druganaut July 24, 2012 Blog Post.    


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 24, 2012 Blog Post titled, “2 Detailed Guides To The New FDA Safety & Innovation Act (FDASIA) – Implementation Impacts” 

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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