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...

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Detalles Bibliográficos
Autores principales: Miller, Kathleen L., Mueller, Christine, Liu, Gumei, Miller Needleman, Katherine I., Maynard, Janet
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2020
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7469294/
https://www.ncbi.nlm.nih.gov/pubmed/32883327
http://dx.doi.org/10.1186/s13023-020-01514-5

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