According to Section 902 of FDASIA, the term "a drug as a breakthrough" appears it may/is intended to ensure that drugs (treating a serious or life-threatening disease or condition) with preliminary clinical evidence (e.g., dramatic Phase I results) follow the shortest possible route to demonstrate safety and efficacy instead of following the common development pathway.
The term "preliminary clinical evidence" indicates that the drug may demonstrate "
substantial improvement over existing therapies on one or more clinically significant endpoints," such as "substantial treatment effects observed early in clinical development. [Emphasis added]
Taken together and practically speaking, it is reasonable to speculate that the drug review process will be fast (as a recent example, Kalydeco's approval).
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www.RegulatoryDoctor.com Floyd VA
United States
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Original Message:
Sent: 08-06-2012 16:19
From: Natalia Shunmugan
Subject: "Breakthrough" Drug Designation
I was wondering if anyone has more information on the new "breakthrough" drug designation created under FDASIA. So far FDA have only given a definition of the category. What does this mean from a practical perspective, and any word on the process?
Thanks!
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Natalia Shunmugan
Manager, Regulatory Affairs Intelligence
Gilead Sciences
Foster City CA
United States
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