Common Commentary on Paediatric Oncology Drug Development Published: Another Step in Optimising Global Regulatory Coordination of Paediatric Development Plans.
Journal
Therapeutic innovation & regulatory science
ISSN: 2168-4804
Titre abrégé: Ther Innov Regul Sci
Pays: Switzerland
ID NLM: 101597411
Informations de publication
Date de publication:
11 2021
11 2021
Historique:
received:
25
07
2021
accepted:
01
09
2021
pubmed:
10
9
2021
medline:
16
10
2021
entrez:
9
9
2021
Statut:
ppublish
Résumé
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.
Identifiants
pubmed: 34498227
doi: 10.1007/s43441-021-00339-z
pii: 10.1007/s43441-021-00339-z
pmc: PMC9437832
mid: NIHMS1781498
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1109-1110Subventions
Organisme : Intramural FDA HHS
ID : FD999999
Pays : United States
Informations de copyright
© 2021. The Drug Information Association, Inc.
Références
Clin Pharmacol Ther. 2020 Mar;107(3):507-513
pubmed: 31449664
J Clin Oncol. 2020 Dec 20;38(36):4227-4230
pubmed: 32946356