Implementing the EU in vitro diagnostic regulation – a European regulatory perspective on companion diagnostics
Author:
Affiliation:
1. Scientific and Regulatory Management Department, European Medicines Agency (EMA), Amsterdam, The Netherlands
2. Product Development Scientific Support Department, European Medicines Agency (EMA), Amsterdam, The Netherlands
Funder
funded
Publisher
Informa UK Limited
Subject
Genetics,Molecular Biology,Molecular Medicine,Pathology and Forensic Medicine
Link
https://www.tandfonline.com/doi/pdf/10.1080/14737159.2020.1720653
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5. European Medicines Agency, Committee for Human Medicinal Products. Reflection paper on pharmacogenomics in oncology. 2008 April. [cited 2019 Aug 28]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-pharmacogenomics-oncology_en.pdf
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