New bill to speed approval for breakthrough drugs
May 2012

WASHINGTON, D.C.—A new bipartisan bill has been proposed that would require the U.S. Food and Drug Administration (FDA) to speed up the development and review of breakthrough drugs. With the Advancing Breakthrough Therapies for Patients Act—introduced by Sen. Michael Bennet, D-Colo.; Sen. Orrin Hatch, R-Utah; and Sen. Richard Burr, R-N.C.—if a company believes its drug qualifies, it can request a breakthrough designation, after which the FDA has 60 days to determine the accuracy of the claim. Following designation, the FDA would then meet with the sponsor throughout the drug's development, minimizing the number of patients required in clinical trials and shortening the trials' duration, among other things. The bill also has backing from Friends of Cancer Research and the National Venture Capital Association.   

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