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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...
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| Publicado no: | Orphanet J Rare Dis |
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| Main Authors: | , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
BioMed Central
2020
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| Assuntos: | |
| Acesso em linha: | 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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