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EU, US & Japan Tackle Difficulties With Randomized Trials Involving Multi-Drug Resistant Bacteria

 
• By Neena Brizmohun

The European Medicines Agency has given the Pink Sheet more detail on its recent agreement with its counterparts in the US and Japan to align certain clinical data requirement to stimulate the development of new treatments to fight antimicrobial resistance.

Streamlined
Aligned EU, US and Japanese trial data requirements should stimulate antibiotic development • Source: Shutterstock

Drug regulators in the EU, the US and Japan are seeking to help streamline the development of antibiotics for patients infected with multi-drug resistant (MDR) bacteria by addressing the difficulties developers face when it comes to conducting randomized clinical trials.

The move is part of the agreement that the European Medicines Agency, the Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency announced briefly last week on...

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