Cancer drugs approved for use in children: Impact of legislative initiatives and future opportunities.
FDA
cancer
children
drug approval
Journal
Pediatric blood & cancer
ISSN: 1545-5017
Titre abrégé: Pediatr Blood Cancer
Pays: United States
ID NLM: 101186624
Informations de publication
Date de publication:
08 2019
08 2019
Historique:
received:
04
10
2018
revised:
26
04
2019
accepted:
27
04
2019
pubmed:
31
5
2019
medline:
23
1
2020
entrez:
31
5
2019
Statut:
ppublish
Résumé
It is well appreciated that the number of anticancer drugs approved for use in children is a fraction of the number approved for use in cancers that occur in adults. We address this fact by summarizing the relevant U.S. legislation that provides the framework for the evaluation and approval of drugs used to treat children with cancer. In total, the Food and Drug Administration (FDA) has approved 38 new drug applications for pediatric oncology indications, 12 of which were new molecular entities. FDA continues to collaborate with multistakeholders regarding the development of products intended for pediatric cancer and encourages the submission of marketing applications.
Substances chimiques
Antineoplastic Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e27809Commentaires et corrections
Type : CommentIn
Informations de copyright
Published 2019. This article is a U.S. Government work and is in the public domain in the USA.