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EU Pilot Features ‘All-In-One’ Regulatory Path For Drug/Diagnostic Trials

 
• By Vibha Sharma

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

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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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