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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...

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Detalles Bibliográficos
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