FDA Details Mandatory Drug Warning Label Updates

Law360, New York (July 30, 2013, 5:54 PM EDT) -- The U.S. Food and Drug Administration on Tuesday finalized its approach to mandatory revisions of prescription drug warning labels, a power it gained six years ago in the wake of scandal surrounding deadly side effects of the painkiller Vioxx.

In a guidance document, the FDA made clear it believes it acquired wide latitude from Congress in the Food and Drug Administration Amendments Act of 2007 to demand that labels be updated when regulators encounter “new safety information.”

Such information is defined in statute and includes serious...
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