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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...

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Detalles Bibliográficos
Autores principales: Reis, Mariana E., Bettencourt, Ana, Ribeiro, Helena M.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
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