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New bill to speed approval for breakthrough drugs
May 2012
SHARING OPTIONS:
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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