Working with our partners in all sectors, Friends took ‘Breakthrough’ from concept, to scientific whitepaper, to bipartisan legislative solution, to a tool in full use by FDA to expedite the approval of multiple drugs in 13 months.
On January 7, 2013, only 6 months after being signed into law, the first two Breakthrough designations were announced.
Below are the designations that have been announced so far:Breakthrough Designations Announced By Companies (Updated 5/7/2013):
As knowledge about complex disease such as cancer and HIV/AIDS has expanded, researchers have been able to develop increasingly precise methods of treatment. Targeted therapies, a variety of drugs that targets specific molecular pathways, allow physicians and researchers to identify patients highly likely to respond to treatment. Frequently, these new drugs show major clinical activity and significant improvement over currently available treatment early in their development. In cases where new drugs show so much promise, and particularly in cases where existing treatment options are limited, the traditional multi-phase, sequential drug development process may not be appropriate.
FRIENDS OF CANCER RESEARCH
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