FDA Test-Drives New Risk-Benefit Framework

Law360, New York (September 11, 2012, 7:03 PM EDT) -- In a shift that could benefit drugmakers, the U.S. Food and Drug Administration is testing a new method for weighing the safety risks of a new pharmaceutical against its potential benefits, putting special focus on whether the drug would fill a gap in current treatments, agency officials said Tuesday.

The FDA has been testing the new framework, a more structured approach than the agency has traditionally used, in five new drug applications for several months, and recently started on a sixth, said Patrick Frey, director of...
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