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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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Bibliografische gegevens
Gepubliceerd in:Clin Transl Sci
Hoofdauteurs: Mueller, Christine M., Rao, Gayatri R., Miller Needleman, Katherine I.
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: John Wiley and Sons Inc. 2019
Onderwerpen:
Online toegang:https://ncbi.nlm.nih.gov/pmc/articles/PMC6853264/
https://ncbi.nlm.nih.gov/pubmed/31297924
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1111/cts.12667
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