Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans

被引：0
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作者：
Dominik Karres
Gregory Reaman
Franca Ligas
Giovanni Lesa
Susan McCune
Suzanne Malli
Ralph Bax
Jean Temeck
机构：
[1] European Medicines Agency (EMA),Paediatric Medicines Office, Human Medicines Division, Scientific Evidence Generation Department
[2] U.S. Food and Drug Administration (FDA),Oncology Center of Excellence, Office of the Commissioner, Office of Oncologic Diseases, Office of New Drugs, Center for Drug Evaluation and Research
[3] US Food and Drug Administration (FDA),Office of Pediatric Therapeutics, Office of the Commissioner
来源：
Therapeutic Innovation & Regulatory Science | 2021年 / 55卷
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摘要：
The European Medicines Agency and the US Food and Drug Administration recently published a common commentary document on paediatric oncology drug development, building on the call for simultaneous submissions of paediatric investigation plans and initial pediatric study plans. The objective of this document is to guide deliberations and permit focused discussions at the monthly paediatric cluster calls, allowing early regulatory coordination of global development plans. The differences in regulations related to timeline are not considered posing a barrier in that regard.
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页码：1109 / 1110
页数：1
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