Combating Childhood Cancer: Paediatric Patients Living with Neuroblastoma
- Regulatory Ramifications and Roadblocks

Manfred      Kurz
doi:10.2174/2667337109666221207154414
Abstract

This paper relates to Neuroblastoma (NBL), a rare, solid cancer affecting children and aims to describe regulatory obligations to adhere to during development, marketing authorisation application (MAA) and post-authorisation stage. The focus is on European Union (EU) paediatric legislation, although essential US Food and Drug Administration (FDA) elements are briefly outlined. Practical regulatory aspects and reporting requirements, players in the therapeutic area as well as clinical management are described. The feasibility and limitations of future harmonised clinical development are pointed out.
Keywords: Oncology, children, neuroblastoma, PDCO, SIOPEN, COG, COJEC, GPOH, compliance check, PIP, iPSP, EMA, FDA, orphan drug, induction chemotherapy, immunotherapy, paediatrics, RfM.
Graphical Abstract

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DOI https://dx.doi.org/10.2174/2667337109666221207154414	Print ISSN 2667-3371
Publisher Name Bentham Science Publisher	Online ISSN 2667-338X
Applied Drug Research, Clinical Trials and Regulatory Affairs

Combating Childhood Cancer: Paediatric Patients Living with Neuroblastoma - Regulatory Ramifications and Roadblocks

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