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Oncology Sponsors Getting A Jump On Pediatric Study Requirements, US FDA Says

 
• By Sue Sutter

Beginning in August 2020, applications for some novel cancer drugs and biologics will have to include reports on molecularly targeted pediatric investigations; agency is already working with sponsors on pediatric study development plans and expects to issue two draft guidances soon.

Child patient with IV line in hand sleep on hospital bed with hands of mother or doctor holding together to support ill daughter.Medical palliation healthcare concept

The US FDA is helping sponsors get a jump on pediatric cancer study requirements that take effect in August 2020 and is close to issuing two new guidance documents explaining how those provisions will be implemented.

Under the RACE for Children Act provisions that were included in the FDA Reauthorization Act, applications for novel drugs and...

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