Oncology Benefits Most From EMA-FDA Pediatrics 'Cluster' Informal Advice
This article was originally published in The Pink Sheet Daily
FDA and EMA staffers talk monthly on topics related to pediatric uses, resulting in 15 non-binding joint commentaries.
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The European Medicines Agency is working on plans to supplement its early advice pilot on pediatric development by providing joint advice with the US FDA and, in some cases, by arranging for a three-way dialogue with companies.
EMA has gotten applications from sponsors for early advice on developing medicines for pediatric indications, under one-year pilot project.
FDA's authority to issue vouchers with new treatments for rare pediatric diseases expires in March 2016 unless Congress intervenes to extend the program.