加速儿科癌症药物的全球开发：呼吁协调向欧洲药品管理局和美国食品药品监督管理局提交儿科研究计划和儿科研究方案 - Suppr

Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration.

作者信息

Reaman Gregory, Karres Dominik, Ligas Franca, Lesa Giovanni, Casey Denise, Ehrlich Lori, Norga Koen, Pazdur Richard

机构信息

Oncology Center of Excellence, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.

Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.

出版信息

J Clin Oncol. 2020 Dec 20;38(36):4227-4230. doi: 10.1200/JCO.20.02152. Epub 2020 Sep 18.

DOI:10.1200/JCO.20.02152

PMID:32946356

Abstract

摘要

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Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration.

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Accelerating the Global Development of Pediatric Cancer Drugs: A Call to Coordinate the Submissions of Pediatric Investigation Plans and Pediatric Study Plans to the European Medicines Agency and US Food and Drug Administration.

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