2011-2023年FDA批准儿童孤儿药适应症

IF 24.7 1区医学 Q1 PEDIATRICS

JAMA Pediatrics Pub Date : 2024-12-09 DOI:10.1001/jamapediatrics.2024.5280

Apoorva Kakkilaya, Mahnum Shahzad, Florence T. Bourgeois

引用次数: 0

摘要

本队列研究评估了《儿科研究公平法》修正案，该修正案可能会影响当前监管项目下儿科患者孤儿药适应症的批准。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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FDA Approval of Orphan Drug Indications for Pediatric Patients, 2011-2023

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

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来源期刊

JAMA Pediatrics PEDIATRICS-

CiteScore

31.60

自引率

1.90%

发文量

357

期刊介绍： JAMA Pediatrics, the oldest continuously published pediatric journal in the US since 1911, is an international peer-reviewed publication and a part of the JAMA Network. Published weekly online and in 12 issues annually, it garners over 8.4 million article views and downloads yearly. All research articles become freely accessible online after 12 months without any author fees, and through the WHO's HINARI program, the online version is accessible to institutions in developing countries. With a focus on advancing the health of infants, children, and adolescents, JAMA Pediatrics serves as a platform for discussing crucial issues and policies in child and adolescent health care. Leveraging the latest technology, it ensures timely access to information for its readers worldwide.