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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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Bibliografiske detaljer
Udgivet i:Clin Transl Sci
Main Authors: Mueller, Christine M., Rao, Gayatri R., Miller Needleman, Katherine I.
Format: Artigo
Sprog:Inglês
Udgivet: John Wiley and Sons Inc. 2019
Fag:
Online adgang: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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