FDA gets serious about pediatric testing
February 1, 1999 less than 1 minute read
FDA gets serious about pediatric testing
Just after Thanksgiving, the U.S. Food and Drug Administration adopted a final regulation requiring pediatric testing, data, and label information for new drugs coming to market or for available drugs commonly prescribed to children.
The regulation targets new drugs with therapeutic potential or direct indications for children, and it allows the FDA to demand pediatric testing and labeling when off-label uses could be risky. The move, part of a Clinton administration children’s health initiative, follows a 1994 voluntary pediatric data program the agency says fell short of expectations. Waiver provisions can allow drug approval for adults while pediatric testing remains ongoing, if the drug is obviously one that will not be used on children, or if the agency deems that reasonable testing efforts are impossible.
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