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www.fdanews.com/articles/138887-fda-outlines-process-for-505-o-4-drug-safety-labeling-requirements

FDA Outlines Process for 505(o)(4) Drug Safety Labeling Requirements

August 2, 2011
With the passage in September 2007 of the FDA Amendments Act (FDAAA), the agency was given more power to require — and, if necessary, order — drug and biologics makers to make postmarket changes to product labeling if serious new safety issues come to light.
The Food & Drug Letter