Cargando…
Precision Medicines’ Impact on Orphan Drug Designation
The incentives provided under the Orphan Drug Act (ODA) have been credited for catalyzing the marketing approval of drugs for the treatment of rare diseases by the US Food and Drug Administration. Orphan drug designation, the granting of special status to drugs or biologics (“drugs”) for the treatme...
Autores principales: | Mueller, Christine M., Rao, Gayatri R., Miller Needleman, Katherine I. |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2019
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6853264/ https://www.ncbi.nlm.nih.gov/pubmed/31297924 http://dx.doi.org/10.1111/cts.12667 |
Ejemplares similares
-
FDA orphan products clinical trial grants: assessment of outcomes and impact on rare disease product development
por: Miller, Kathleen L., et al.
Publicado: (2020) -
Do investors value the FDA orphan drug designation?
por: Miller, Kathleen L.
Publicado: (2017) -
A comprehensive study of the rare diseases and conditions targeted by orphan drug designations and approvals over the forty years of the Orphan Drug Act
por: Fermaglich, Lewis J., et al.
Publicado: (2023) -
Impact of orphan drugs on Latvian budget
por: Logviss, Konstantins, et al.
Publicado: (2016) -
Use of biomarkers in the context of orphan medicines designation in the European Union
por: Tsigkos, Stelios, et al.
Publicado: (2014)