Changes in the regulation of IVDs in Europe could result in growing differences between how the EU and US regulate personalized medicine, including companion diagnostics. That is the view of Hogan Lovells' US-based life-sciences and health-care partner, Randy Prebula.
Prebula, who focuses on US FDA device and IVD issues, said in an interview with Medtech Insight that there is already quite a distinction between the EU and US regulatory...
Where Things Stand
IVDs play a key role in personalized medicine in assessing the genetic make-up of a patient to help ensure the selection of the best drug or other therapies for...
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Medtech Insight for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?