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One Year Post Exclusivity Adverse Event Monitoring as mandated by the Best Pharmaceuticals for Children Act

One Year Post Exclusivity Adverse Event Monitoring as mandated by the Best Pharmaceuticals for Children Act. Dr. Solomon Iyasu Medical Team Leader Dr. ShaAvhree Buckman Medical Officer Division of Pediatric Drug Development Center for Drug Evaluation and Research Food and Drug Administration.

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One Year Post Exclusivity Adverse Event Monitoring as mandated by the Best Pharmaceuticals for Children Act