Home » FDA Outlines Process for 505(o)(4) Drug Safety Labeling Requirements
FDA Outlines Process for 505(o)(4) Drug Safety Labeling Requirements
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
The Food & Drug Letter
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