Open AccessCommon Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans
Author(s) -
Dominik Karres,
Gregory H. Reaman,
Franca Ligas,
Giovanni Lesa,
Susan K. McCune,
Suzanne Malli,
Ralph Bax,
Jean Temeck
Publication year - 2021
Publication title -
therapeutic innovation and regulatory science
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.569
H-Index - 44
eISSN - 2168-4804
pISSN - 2168-4790
DOI - 10.1007/s43441-021-00339-z
Subject(s) - timeline , drug development , pharmacy , regulatory science , agency (philosophy) , pediatric oncology , medicine , regulatory agency , food and drug administration , medical education , drug , pharmacology , political science , family medicine , public administration , cancer , pathology , geography , philosophy , archaeology , epistemology
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.