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US FDA Could Require Pediatric Cancer Drug Combo Studies Under Amended User Fee Bill

 
• By Brenda Sandburg

House Energy & Commerce Committee adds Give Kids a Chance Act to user fee reauthorization package during markup. Bill was modified to exclude provision giving the FDA authority to require preclinical studies.

Pediatric cancer
Pediatric studies of investigational cancer drug combinations could be required by FDA under amended user fee bill • Source: Shutterstock

The US Food and Drug Administration would be authorized to require companies developing new combinations of cancer drugs to conduct pediatric studies under an amendment to user fee reauthorization legislation adopted by the House Energy & Commerce Committee.

At its 18 May markup of the measure, the committee voted unanimously in favor of an amendment by Rep. G.K....

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