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  • Provides criteria for FDA to waive or defer pediatric studies and requires a plan for deferred studies. Deferrals may be granted if the drug is ready to be approved in the adult population, or if additional safety information is needed before use in the pediatric population, or other reasons. Waivers can be granted if the drug will have limited use in children, if it is thought that the product will be ineffective or unsafe in children or if an appropriate pediatric formulation cannot be made. Final deferral and waiver decisions are made when the application is approved. If a waiver is granted for a pediatric population for safety reasons or lack of efficacy, the safety issue or lack of efficacy must be noted in the labeling.
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Topic: page 2 of 4 (Lesson: page 11 of 24)