Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Nat Rev Drug Discov
; 9(6): 435-45, 2010 06.
Article
en En
| MEDLINE
| ID: mdl-20514070
ABSTRACT
Heterogeneity in the underlying mechanisms of disease processes and inter-patient variability in drug responses are major challenges in drug development. To address these challenges, biomarker strategies based on a range of platforms, such as microarray gene-expression technologies, are increasingly being applied to elucidate these sources of variability and thereby potentially increase drug development success rates. With the aim of enhancing understanding of the regulatory significance of such biomarker data by regulators and sponsors, the US Food and Drug Administration initiated a programme in 2004 to allow sponsors to submit exploratory genomic data voluntarily, without immediate regulatory impact. In this article, a selection of case studies from the first 5 years of this programme - which is now known as the voluntary exploratory data submission programme, and also involves collaboration with the European Medicines Agency - are discussed, and general lessons are highlighted.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
United States Food and Drug Administration
/
Aprobación de Drogas
/
Perfilación de la Expresión Génica
Tipo de estudio:
Diagnostic_studies
/
Prognostic_studies
Límite:
Humans
País/Región como asunto:
America do norte
/
Europa
Idioma:
En
Revista:
Nat Rev Drug Discov
Asunto de la revista:
FARMACOLOGIA
/
TERAPIA POR MEDICAMENTOS
Año:
2010
Tipo del documento:
Article
País de afiliación:
Estados Unidos