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FDA pediatric research list includes 23 OTC drugs requiring more data.

This article was originally published in The Tan Sheet

Executive Summary

FDA DRAFT PEDIATRIC RESEARCH LIST INCLUDES 23 OTC DRUGS for which additional pediatric information could produce health benefits in the pediatric population. Criteria for inclusion in the list include whether a drug product, if approved for a pediatric population, "would be a significant improvement compared to marketed products labeled for use in the treatment, diagnosis, or prevention of a disease in the relevant pediatric population." If a drug "is in a class or for an indication for which additional therapeutic options for the pediatric population are needed," it also would qualify for inclusion on the list.
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