Bridging Gaps in Oncology: Comparative Analysis of Development and Approval Pathways for Anticancer Drugs and Companion Diagnostic in the United States and Japan

ABSTRACT Companion diagnostics (CDxs) are essential in personalized medicine for oncology, where specific genetic mutations drive treatment decisions. Some differences remain in the regulatory frameworks and approval processes for CDx between the United States (U.S.) and Japan. Data were collected f...

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Bibliografische gegevens
Hoofdauteurs: Kaku Saito, Mamoru Narukawa
Formaat: Artigo
Taal:Inglês
Gepubliceerd in: Wiley 2025-02-01
Reeks:Clinical and Translational Science
Onderwerpen:
companion diagnostics
oncology
post‐marketing commitment
regulatory science
Online toegang:https://doi.org/10.1111/cts.70162
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