ArticleFrontiers in medicine2022
Mandatory requirements for pediatric drug development in the EU and the US for novel drugs-A comparative study.
Article in Frontiers in medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
What it found
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Who cites it
3 citing papers in PubMed, 5 citations in OpenAlex.
- Off-label prescribing in pediatrics: between regulatory gaps and clinical evidence.Italian journal of pediatrics · 2026Article
- Three-Dimensionally Printed Paediatric Medicines: Formulation, Process, and Regulatory Considerations.Pharmaceutics · 2025Review
- Addressing the drug development challenge for rare pediatric diseases in Japan: a case study of isotretinoin.Investigational new drugs · 2025Review
Corrections and comments
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Authors and funding
3 authors at 1 institution in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 granted for similar drugs across jurisdictions. This cross-sectional study compares the pediatric requirements for therapeutic indications granted at the time of initial approval for novel drugs approved in the two regions from 2010 to 2018. We collected the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) decisions to grant a waiver and/or to agree on a pediatric development plan and deferrals hereof at marketing authorization (MA) from publicly available documents. An agreed pediatric development plan was required for 66% (
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