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Regulatory Standards in Orphan Medicinal Product Designation in the EU
Twenty years of orphan regulation in Europe have now elapsed, with almost 2,400 orphan designated medicinal products and more than 190 orphan products authorised in the EU. Alongside the evolution in understanding of rare diseases, considerable regulatory knowledge has also been accumulated regardin...
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| Publicado no: | Front Med (Lausanne) |
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| Main Authors: | , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
Frontiers Media S.A.
2021
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC8268149/ https://ncbi.nlm.nih.gov/pubmed/34249982 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.3389/fmed.2021.698534 |
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