This cohort study assesses Pediatric Research Equity Act amendments that may influence approval of orphan drug indications for pediatric patients under current regulatory programs.

中文翻译：

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FDA 批准儿科孤儿药适应症，2011-2023 年


该队列研究评估了《儿科研究公平法案》修正案，这些修正案可能影响当前监管计划下儿科患者孤儿药适应症的批准。