Regulatory benefit-risk assessment of oncology drugs: A systematic review of FDA and EMA approvals.
Drug Discov Today
; 28(10): 103719, 2023 10.
Article
en En
| MEDLINE
| ID: mdl-37467877
ABSTRACT
The European Medicines Agency (EMA) and FDA have policy goals of strengthening benefit-risk (B-R) capabilities; but how this has been translating into regulatory practice is unclear. A systematic review of oncology drug approvals between 2015 and 2020 was conducted with approvals identified through review of FDA and EMA annual reports, with extraction of information on submission, clinical program and B-R assessment from publicly available review documents. Data were extracted from 236 reviews (EMA 66 new submissions, 100 label extensions; FDA 70 new submissions). The standard of evidence for B-R assessments seems to have diversified over time; yet, despite policy targets to extend their use, these assessments rarely include patient experience or real-world data.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Aprobación de Drogas
/
Oncología Médica
Tipo de estudio:
Etiology_studies
/
Risk_factors_studies
/
Systematic_reviews
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Drug Discov Today
Asunto de la revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2023
Tipo del documento:
Article