Labeling Changes And FDA's Oversight Of Drug Safety

Law360, New York (May 13, 2008, 12:00 AM EDT) -- Enacted on Sept. 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) gives the FDA enhanced authorities regarding the post-market safety of drugs.[1]

Such authorities range from requiring post-market studies (phase IV trials) and risk evaluation and mitigation strategies (REMS), to triggering a process to rapidly amend drug product labeling when new safety information comes to light.[2]

The primary post-market drug safety provisions of the FDAAA became effective on March 25, 2008.[3]

Of particular interest are the provisions on safety labeling changes requested...
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