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This disparity could be related to the fact that many oncology drugs have had orphan medication designation and were exempt from Pediatric Research Equity Act (PREA) demands. On August 18, 2017, the RACE for Children Act, i.e. Research to Accelerate Cures and Equity Act, ended up being finalized into legislation as Title V associated with 2017 FDA Reauthorization Act (FDARA) to amend the PREA. Pediatric investigation is now needed in the event that medicine or biological item is intended

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