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US FDA May Prioritize Pediatric Cancer Studies By Level Of 'Substantial Relevance'

 
• By Sue Sutter

Assessing the extent of a molecular target's substantial relevance to pediatric cancer could give sponsors more regulatory certainty as to whether they likely would be required to conduct pediatric investigations early in a drug’s development, US FDA's Gregory Reaman says at advisory committee review of molecular target candidate lists.

FDA Advisory Committee Feature image

The US FDA may prioritize the need for pediatric studies of new cancer drugs based on how substantially relevant a drug’s molecular target is to the development and growth of pediatric cancer, rather than just whether the target is or is not substantially relevant at all.

Speaking at a June 20 meeting of the Oncologic Drugs Advisory Committee’s pediatric subcommittee, Gregory Reaman, associate director for pediatric...

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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

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