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Pediatric chronic therapy use supplements should include long-term safety data on development -- FDA guidance.

Executive Summary

PEDIATRIC CHRONIC THERAPY USE SUPPLEMENT SHOULD HAVE DATA ON CHILD DEVELOPMENT safety that is long- term and supports the agent's use in a pediatric population, according to FDA's guidance on the "Content and Format for Pediatric Use Supplements." For drugs used on a "chronic basis in the pediatric population, long-term safety data, including data on growth and development, in particular neurofunctional development, sexual maturation and nutrition" should be included in the pediatric use supplement, the guidance states.
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PS028274

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