Please follow https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-clinical-pharmacology-considerations-neonatal-studies-drugs-and-biological-products-guidance.

Please follow https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-clinical-pharmacology-considerations-neonatal-studies-drugs-and-biological-products-guidance.