1.
JAMA
; 330(24): 2392-2394, 2023 12 26.
Artigo
em Inglês
| MEDLINE
| ID: mdl-38079163
RESUMO
This study evaluates whether FDA-approved novel cancer therapeutics supported by pivotal trials with adequate representation of minoritized groups were associated with slower clinical development times than those with inadequate representation.
Assuntos
Ensaios Clínicos como Assunto , Demografia , Aprovação de Drogas , Neoplasias , Humanos , Oncologia , Neoplasias/terapia , Estados Unidos , United States Food and Drug Administration , Difusão de Inovações , Fatores de Tempo
2.
JAMA Netw Open
; 6(8): e2331753, 2023 Aug 01.
Artigo
em Inglês
| MEDLINE
| ID: mdl-37651145
RESUMO
This cross-sectional study evaluates the duration between application to US Food and Drug Administration (FDA) and approval for new drugs and biologics in the US from 2015 to 2022.
