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EU Pilots Streamlined Approach To Multinational Combination Product Trials

 
• By Vibha Sharma

EU regulators have approved a strategy to streamline the submission and approval of studies that involve the simultaneous investigation of a medicinal product, an IVD, and/or a medical device. The strategy involves rolling out seven cross-sector projects over the next few years.

Plane taking off
The FDA/EMA CoGenT Pilot program for gene therapies is taking flight. • Source: Shutterstock
Key Takeaways
  • A new EU strategy to streamline the conduct of combined studies involving medicinal products, IVDs and medical devices has been endorsed by member states.

EU member states have endorsed plans for several new projects to address the existing bottlenecks...

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