Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway.
JAMA
; 329(9): 760-761, 2023 03 07.
Article
em En
| MEDLINE
| ID: mdl-36705931
This study examines the Food and Drug Administration's accelerated approval pathway and whether preapproval initiation was associated with faster conversion to traditional approval or withdrawal for drugs with nononcology indications.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
United States Food and Drug Administration
/
Aprovação de Drogas
Tipo de estudo:
Risk_factors_studies
País/Região como assunto:
America do norte
Idioma:
En
Revista:
JAMA
Ano de publicação:
2023
Tipo de documento:
Article