Scientific and regulatory progress in advancing paediatric oncology drug development in the EU and in the US
Both regions are working to advance paediatric oncology medicines. However, a significant gap still exists between the EU and the US, with the EU lagging behind. This discrepancy should be a priority for Europe. It is unlikely that abolishing the Paediatric Regulation, proposed as part of the Pharmaceutical Legislation reform, in the absence of other initiatives and substantial investments, would be the right solution.
Authors
- Mariagrazia Felisi (ORCID: https://orcid.org/0000-0002-7315-0857)
- Nicola Santoro (ORCID: https://orcid.org/0000-0001-8853-6536)
- Donato Bonifazi (ORCID: https://orcid.org/0000-0003-2636-9159)
- Giorgio Reggiardo (ORCID: https://orcid.org/0000-0003-4237-6797)
- Viviana Giannuzzi (ORCID: https://orcid.org/0000-0002-2534-6783)
- Claudia Pansieri (ORCID: https://orcid.org/0000-0002-0976-7756)
- Adriana Ceci (ORCID: https://orcid.org/0000-0002-8778-3612)
- A. Natale
Institutions
- Consorzio per Valutazioni Biologiche e Farmacologiche (IT)
- European Centre for Training and Research in Earthquake Engineering (IT)
- Fondazione per la Ricerca Farmacologica Gianni Benzi Onlus (IT)
- University of Bari Aldo Moro (IT)
Publication Details
- Journal
- Frontiers in Medicine
- Published
- 2025-09-26
- DOI
- https://doi.org/10.3389/fmed.2025.1642279
- Primary Topic
- Childhood Cancer Survivors' Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00