Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA

During the last decade, a plethora of novel therapies containing live microorganisms as active substance(s) has emerged with the aim to treat, prevent, or cure diseases in human beings. Both the Food and Drug Administration (FDA) and the European Directorate for the Quality of Medicines and Health C...

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Detalles Bibliográficos
Autores principales: Paquet, Jeanne-Céleste, Claus, Sandrine P., Cordaillat-Simmons, Magali, Mazier, Wilfrid, Rawadi, Georges, Rinaldi, Laure, Elustondo, Frédéric, Rouanet, Alice
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8385711/
https://www.ncbi.nlm.nih.gov/pubmed/34458291
http://dx.doi.org/10.3389/fmed.2021.716266

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8385711/
https://www.ncbi.nlm.nih.gov/pubmed/34458291
http://dx.doi.org/10.3389/fmed.2021.716266

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