Implementing the EU in vitro diagnostic regulation – a European regulatory perspective on companion diagnostics

Author:

Ritzhaupt Armin1ORCID,Hayes Ivana1,Ehmann Falk2

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

Reference23 articles.

1. Use of Chemotherapy plus a Monoclonal Antibody against HER2 for Metastatic Breast Cancer That Overexpresses HER2

2. The Development of the HercepTest

3. The drug diagnostic co-development concept paper

4. US FDA. Guidance for industry and food and drug administration staff. In Vitro Companion Diagnostic Devices. [cited 2019 Aug 28]. Available from: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM262327.pdf

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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