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

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

Gregory Reaman^{1

2}, Dominik Karres³, Franca Ligas³, Giovanni Lesa³, Denise Casey², Lori Ehrlich², Koen Norga^{4

5}, Richard Pazdur^{1

2}

¹ Oncology Center of Excellence, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.
² Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD.
³ Paediatric Medicines Office, Scientific Evidence Generation Department, Human Medicines Division, European Medicines Agency, Amsterdam, the Netherlands.
⁴ Federal Agency for Medicines and Health Products and Paediatric Oncology, Antwerp University Hospital, Edegem, Belgium.
⁵ European Medicines Agency's Paediatric Committee, European Medicines Agency, Amsterdam, the Netherlands.

No abstract available

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