Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency

With the implementation of the new EU regulation on in vitro diagnostics (IVDR) in May 2022, notified bodies will be required to assess Companion Diagnostics (CDx). The EMA and national medicines agencies will be consulted on the performance and safety of CDx. In this paper, we report on our systema...

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Detalles Bibliográficos
Autores principales: Maliepaard, Marc, Nibi, Priscilla, Nibi, Gabrièlla, Pasmooij, Anna M. G.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9120537/
https://www.ncbi.nlm.nih.gov/pubmed/35602486
http://dx.doi.org/10.3389/fmed.2022.893028

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9120537/
https://www.ncbi.nlm.nih.gov/pubmed/35602486
http://dx.doi.org/10.3389/fmed.2022.893028

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