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...
To view the full article, register now.

UK Financial Services

UK Financial Services

Read Our Latest UK Financial Services Coverage

Financial Services Law360 UK provides breaking news and analysis on the financial sector. Coverage includes UK and European Union policy, enforcement, and litigation involving banks, asset management firms, and other financial services organizations.