Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS-Reference-Cited by-同舟云学术

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

Published:2023-09 Issue: Volume:30 Page:447-458
ISSN:2329-0501
Container-title:Molecular Therapy - Methods & Clinical Development
language:en
Short-container-title:Molecular Therapy - Methods & Clinical Development

Author:

Kang Su Lim,Woo Jae Hyun,Kim Na Hyeon,Kwon Ji Yean,Kim Sung Min^ORCID

Publisher

Elsevier BV

Subject

Genetics,Molecular Biology,Molecular Medicine

Reference21 articles.

1. Challenges in the clinical implementation of precision medicine companion diagnostics;Keeling;Expert Rev. Mol. Diagn.,2020

2. Companion diagnostics: a regulatory perspective from the last 5 years of molecular companion diagnostic approvals;Roscoe;Expert Rev. Mol. Diagn.,2015

3. Companion Diagnostics and Targeted Therapy at the Korean Health Technology Assessment Context;Choi;J Health Tech Assess,2016

4. Implementation of the new EU IVD regulation-urgent initiatives are needed to avert impending crisis;Cobbaert;Clin. Chem. Lab. Med.,2022

5. Companion and complementary diagnostics: Clinical and regulatory perspectives;Jørgensen;Trends Cancer,2016

Cited by 1 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Twenty-five years with companion diagnostics;Chinese Clinical Oncology;2023-12

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