Feb 11, 2014
By: Tiffany Farchione M.D., Division of Psychiatry Products, Food and Drug Administration
FDA-approved labeling helps guide doctors’ treatment choices. However, when a medication has not been studied in children, there is no information in the FDA-approved label to guide prescribing for this age group. This can lead to what is known as “off-label” use of a prescription drug.
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