The potential investment impact of improved access to accelerated approval on the development of treatments for low prevalence rare diseases

BACKGROUND: Over 95% of rare diseases lack treatments despite many successful treatment studies in animal models. To improve access to treatments, the Accelerated Approval (AA) regulations were implemented allowing the use of surrogate endpoints to achieve drug approval and accelerate development of...

Descripción completa

Detalles Bibliográficos
Autores principales: Miyamoto, Brigitta E, Kakkis, Emil D
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2011
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149566/
https://www.ncbi.nlm.nih.gov/pubmed/21733145
http://dx.doi.org/10.1186/1750-1172-6-49

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3149566/
https://www.ncbi.nlm.nih.gov/pubmed/21733145
http://dx.doi.org/10.1186/1750-1172-6-49

Ejemplares similares