Impact of the new European Union <i>In Vitro</i> Diagnostics Regulation on the practice of hospital diagnostic laboratories-Reference-Cited by-同舟云学术

Impact of the new European Union In Vitro Diagnostics Regulation on the practice of hospital diagnostic laboratories

Published:2022-05-04 Issue:5 Volume:22 Page:583-590
ISSN:1473-7159
Container-title:Expert Review of Molecular Diagnostics
language:en
Short-container-title:Expert Review of Molecular Diagnostics

Author:

Hermans Audrey M.M¹,Maliepaard Marc¹²^ORCID,Boon Wouter P.C.³^ORCID,Pasmooij Anna M.G.¹^ORCID

Affiliation:

1. Dutch Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands

2. Department of Pharmacology and Toxicology, Radboud University Medical Centre, Nijmegen, The Netherlands

3. Copernicus Institute of Sustainable Development, Utrecht University, Utrecht, The Netherlands

Publisher

Informa UK Limited

Subject

Genetics,Molecular Biology,Molecular Medicine,Pathology and Forensic Medicine

Link

https://www.tandfonline.com/doi/pdf/10.1080/14737159.2022.2087508

Reference30 articles.

1. Targeted therapy in metastatic colorectal cancer – An example of personalised medicine in action

2. The new EU regulation on in vitro diagnostics: potential issues at the interface of medicines and companion diagnostics

3. diaglobal.org: driving co-development of therapeutic drugs and companion diagnostics: increased regulatory focus on precision medicine in China. [Internet]. 2020 Dec cited 2021 Sep 2] Available from 2021 Sep 2: https://globalforum.diaglobal.org/issue/december-2020/driving-co-development-of-therapeutic-drugs-and-companion-diagnostics/

4. Regulation (EU) 2017/746 of the European Parliament and of the council of 5 April 2017 on in vitro diagnostic medical devices and repealing directive 98/79/EC and commission decision 2010/227/EU.

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