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EU Tests Unified Pathway For Combined Drug/IVD Studies

 
• By Vibha Sharma

The EU is testing a groundbreaking “all-in-one” process for reviewing requests to conduct combined drug and diagnostic trials via a single application for coordinated assessment.

A stack of wooden blocks with arrows pointing upwards and target board. Mission, focus, ladder of success concept.
EU is taking a phased approach to streamlining combined drug/IVD study approvals (Shutterstock)
Key Takeaways
  • EU regulators have initiated a pilot to streamline the regulatory and ethics review process for combined clinical trials of medicines and in vitro diagnostics, aiming to reduce administrative burden on sponsors and accelerate patient access to innovative treatments.

Sponsors planning to run multinational combined studies in the EU that involve both the clinical trials of medicines and the...

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