Regulations for Companion Diagnostics in the US and EU
Questions? Request more information from our specialists
CONTACT USAre you marketing a companion diagnostics (CDx) product? If so, you already know two things: first, CDx products are powerful tools in precision medicine. Second, they come with some unique regulatory challenges because they are considered pharmaceuticals and medical devices.
The United States and Europe take a unique approach to regulating these innovative devices. In this paper, we answer your biggest questions about the obstacles and opportunities of marketing companion diagnostics in the US and Europe.
What you will learn in this 5-page white paper:
- How have regulations for CDx products evolved over time?
- How do regulations in the US and Europe apply to CDx products?
- How to time drug and diagnostic approvals?
- What business and development obstacles do I face with a CDx product?
We answer all of these questions and many more in this white paper.
About the Author:
Oliver Eikenberg, PhD is Senior QA/RA Consultant at Emergo's office in Hamburg, Germany. His areas of expertise include QMS implementations and regulatory submissions in the US and Europe, particularly for IVDs in the areas of neurology, infectious disease, autoimmune disorders, cancer, genetic markers, and CDx. He holds a PhD in chemistry from the Technical University of Munich.
Related
-
WATCH NOW: Risk Management according to EN ISO 14971:2012
Since the publication of ISO 13485:2016, risk management is a major concern for maintaining regulatory compliance in major medical device markets.
read more -
Sweden – Overview of medical device industry and healthcare statistics
Below you will find basic demographic and economic data for Sweden, plus specific information about the country's medical device and healthcare ind
read more