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FDA orphan products clinical trial grants: assessment of outcomes and impact on rare disease product development

BACKGROUND: The Office of Orphan Products Development (OOPD) of the United States (U.S.) Food and Drug Administration (FDA) has awarded over 700 grants to conduct clinical trials of medicals products for rare diseases since 1983, leading to over 70 marketing approvals. However, despite recent progre...

Deskribapen osoa

Gorde:
Xehetasun bibliografikoak
Argitaratua izan da:Orphanet J Rare Dis
Egile Nagusiak: Miller, Kathleen L., Mueller, Christine, Liu, Gumei, Miller Needleman, Katherine I., Maynard, Janet
Formatua: Artigo
Hizkuntza:Inglês
Argitaratua: BioMed Central 2020
Gaiak:
Sarrera elektronikoa:https://ncbi.nlm.nih.gov/pmc/articles/PMC7469294/
https://ncbi.nlm.nih.gov/pubmed/32883327
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1186/s13023-020-01514-5
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