1.
Ther Innov Regul Sci
; 55(6): 1109-1110, 2021 11.
Artigo
em Inglês
| MEDLINE
| ID: mdl-34498227
RESUMO
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.