We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
Home » FDA Outlines Process for 505(o)(4) Drug Safety Labeling Requirements
FDA Outlines Process for 505(o)(4) Drug Safety Labeling Requirements
July 27, 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.