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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...

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Detalles Bibliográficos
Autores principales:	Hanaizi, Zahra, Kweder, Sandra, Thor, Shannon, Ribeiro, Sonia, Marcal, Anabela
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	Springer International Publishing 2022
Materias:	Original Research
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

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