Mandatory requirements for pediatric drug development in the EU and the US for novel drugs—A comparative study
Mandatory pediatric legislation has been implemented in the European Union (EU) and the United States (US) to increase research and the availability of drugs for the pediatric population. Differences in the legislative framework can cause different pediatric requirements for similar indications gran...
Main Authors: | Helle Christiansen, Marie L. De Bruin, Christine E. Hallgreen |
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Format: | Article |
Language: | English |
Published: |
Frontiers Media S.A.
2022-10-01
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Series: | Frontiers in Medicine |
Subjects: | |
Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2022.1009432/full |
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