FDA Breakthrough Therapy Designation: 2013 In Review

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Orphan Druganaut Blog

As most of the Blog’s readers already know, FDASIA, or the FDA Safety and Innovation Act (S. 3187) is enacted after President Obama signs it in July 2012. FDASIA is a big step towards developing effective and safe treatments for rare diseases and orphan drug development in the United States. The legislation is to have an important and large impact on the future of accelerating new medical treatments for patient access.

It is in Section 902 of FDASIA, that the new FDA Breakthrough Therapy Designation (BTD) is described. To expedite the development and review of drugs for life-threatening and serious diseases, the FDA had three programs before the BTD is created :

•   Fast Track
•   Accelerated Approval
•   Priority Review.

The three Designations are in existence for at least 20 years. What is different about the BTD is the “ … requirement of early clinical data demonstrating an unprecedented…

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