1.
JAMA
; 330(24): 2392-2394, 2023 12 26.
Artículo
en Inglés
| MEDLINE
| ID: mdl-38079163
RESUMEN
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.
Asunto(s)
Ensayos Clínicos como Asunto , Demografía , Aprobación de Drogas , Neoplasias , Humanos , Oncología Médica , Neoplasias/terapia , Estados Unidos , United States Food and Drug Administration , Difusión de Innovaciones , Factores de Tiempo
2.
JAMA Netw Open
; 6(8): e2331753, 2023 Aug 01.
Artículo
en Inglés
| MEDLINE
| ID: mdl-37651145
RESUMEN
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.
