Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling

Regulatory Considerations for the Mother, Fetus and Neonate in Fetal Pharmacology Modeling

The regulatory framework for considering the fetal effects of new drugs is limited. This is partially due to the fact that pediatric regulations (21 CFR subpart D) do not apply to the fetus, and only US Health and Human Service (HHS) regulations apply to the fetus. The HHS regulation 45 CFR Part 46...

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Bibliographic Details
Main Authors: Dionna J. Green, Kyunghun Park, Varsha Bhatt-Mehta, Donna Snyder, Gilbert J. Burckart
Format: Article
Language:English
Published: Frontiers Media S.A. 2021-07-01
Series:Frontiers in Pediatrics
Subjects:
drug development
fetal
regulatory
pediatrics
Food and Drug Administration
model-informed drug development
Online Access:https://www.frontiersin.org/articles/10.3389/fped.2021.698611/full

Internet

https://www.frontiersin.org/articles/10.3389/fped.2021.698611/full

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