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Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations
The United States Food and Drug Administration and the European Medicines Agency (EMA) each have programs to expedite development of products identified as having potential to address unmet medical needs: the Breakthrough therapy (BT) and Regenerative Medicines Advanced Therapies designation program...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9905154/ https://www.ncbi.nlm.nih.gov/pubmed/36307671 http://dx.doi.org/10.1007/s43441-022-00475-0 |