Labeling Changes And FDA's Oversight Of Drug Safety
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.
The primary post-market drug safety provisions of the FDAAA became effective on March 25, 2008.
Of particular interest are the provisions on safety labeling changes requested...
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