One global paediatric cancer development plan instead of separate FDA and EMA plans
Companies must agree separate plans for testing new cancer drugs in children with US and European regulators. A single agreed plan would get children access sooner.
The EU Paediatric Investigation Plan and the US Pediatric Study Plan (strengthened by the RACE for Children Act) are negotiated separately and often specify different trials, ages or endpoints. The ACCELERATE platform and the FDA-EMA Common Commentary have begun to align them. The proposal is a single joint plan with one decision letter and reciprocal deferral and waiver decisions, extended to PMDA and Health Canada, so a paediatric oncology programme is designed once.
- Regulatory divergence between regions · Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive.
- Rare and paediatric cancers without markets · Taken together rare cancers are a fifth of all cancers, but each one alone is too small for a company to invest in.
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not linked directly; found by shared links- IdeaAutomatic reciprocity of orphan and rare-paediatric designations between regulators
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- IdeaMake paediatric combination studies part of every relevant adult cancer drug approval
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- TrialNaxitamab Study 201
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- TermINRG staging and risk groups
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- PersonAlexandra "Alex" Scott
Shares Neuroblastoma (paediatric), Rare and paediatric cancers without markets.