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The regulatory challenges of innovative customized combination products
BACKGROUND/AIMS: Combination products are therapeutic and/or diagnostic products that can combine drugs and medical devices and which increasing complexity has raised new regulatory framework challenges. To reach the market, a combination product must be classified based on the principal mode of act...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9354569/ https://www.ncbi.nlm.nih.gov/pubmed/35935795 http://dx.doi.org/10.3389/fmed.2022.821094 |