Pediatric labeling enforced
Pediatric labeling enforced
Just after Thanksgiving, the U.S. Food and Drug Administration (FDA) adopted a final resolution requiring pediatric testing, data, and label information for new or available drugs commonly prescribed for children. Specifically, the regulation targets new drugs with therapeutic potential or direct indications for children and allows the FDA to demand pediatric testing and labeling when off-label uses could be risky. Waiver provisions can allow drug approval for adults, for use during pediatric testing, if the drug obviously will not be used in children, or if the agency deems that reasonable testing efforts are impossible.
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