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References
1.E11A Pediatric Extrapolation, FDA Guidance , August 2022
2.Additional Safeguards for Children in Clinical Investigations , 21 CFR 50, subpart D
3.Additional Protections for Children Involved as Subjects in Research
4.Ethical Considerations for Clinical Investigations of Medical Products Involving Children, FDA, Draft Guidance , September 2022 , Snapshot Podcast
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