Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS

Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS

Companion diagnostics (CDx), which is essential in precision medicine, is changing to a personalized treatment approach. CDx is a test that identifies patients who can benefit from a specific drug and those who experience side effects of drugs for safe and effective treatment. Conversely, when CDx h...

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Bibliographic Details
Main Authors: Su Lim Kang, Jae Hyun Woo, Na Hyeon Kim, Ji Yean Kwon, Sung Min Kim
Format: Article
Language:English
Published: Elsevier 2023-09-01
Series:Molecular Therapy: Methods & Clinical Development
Subjects:
companion diagnostics
clinical
regulatory
framework
process
Online Access:http://www.sciencedirect.com/science/article/pii/S2329050123001225

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http://www.sciencedirect.com/science/article/pii/S2329050123001225

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