Time Will Tell If FDA Review Update Quickens Drug Approval

Law360, New York (July 10, 2012, 8:08 PM EDT) -- The latest U.S. Food and Drug Administration user fee update aims to reduce new-drug review times by, perhaps counterintuitively, giving the FDA more time for review, but regulatory attorneys say it will take time to know whether the changes will actually get drugs to market faster.

Under the user fee act, which the president signed Monday, the FDA will get an additional 60 days to review applications for new small-molecule and biologic drugs. Currently, the FDA must issue a final decision within 10 months, or six...
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