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FDA Week - 07/14/2017

Portions Of Pediatric Cancer Bill Included In Updated FDARA

July 13, 2017
The House version of the FDA Reauthorization Act (FDARA), which the House passed Wednesday (July 12), includes portions of a bill aimed at increasing development of childhood cancer drugs. Despite having strong bipartisan support, the bill, the Research to Accelerate Cures and Equity (RACE) for Children Act, was kept out of FDARA during user fee markups due to negotiations over implementation issues. RACE for Children updates the Pediatric Research Equity Act (PREA) by requiring drug developers to conduct pediatric studies...


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