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Oncology Benefits Most From EMA-FDA Pediatrics 'Cluster' Informal Advice

 
• By Vibha Sharma

FDA and EMA staffers talk monthly on topics related to pediatric uses, resulting in 15 non-binding joint commentaries.

Oncology and gastroenterology products so far are benefiting the most from a relatively new collaboration between the European Medicines Agency and the US FDA to provide informal parallel scientific advice to developers of selected pediatric medicines under review at both agencies.

Under the collaboration, the pediatric "cluster" of EMA and FDA officials holds monthly teleconferences to discuss product-specific or general pediatric topics of interest, and in some selective cases issue a "common commentary" to inform drug sponsors of the discussions they have had in relation to

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