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Changes in Companion Diagnostic Labelling: Implementation of FDA’s April 2020 Guidance for Industry for In Vitro CDx Labeling for Specific Oncology Therapeutic Groups
Advanced understanding of the molecular pathways of oncologic diseases has shifted therapeutic treatment development to focus on mechanism of actions targeting specific genomic alterations. These precision medicines are indicated for patient subsets defined by these specific mutations as determined...
| Autores principales: | , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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Springer International Publishing
2022
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9356945/ https://www.ncbi.nlm.nih.gov/pubmed/35689144 http://dx.doi.org/10.1007/s43441-022-00422-z |