PRIME-ROSE at ISPOR Europe: Lessons from the Well-Established Use pathway

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PRIME-ROSE was represented at ISPOR Europe with a poster presentation from Work Package4 entitled “Lessons learned from the Well-Established Use Pathway: a retrospective analysis.”

The study examines past applications to the European Medicines Agency (EMA) through the Well-Established Use (WEU) pathway, focusing on the types of evidence used to demonstrate efficacy, safety and established medicinal use.

The findings provide valuable insights into how existing evidence can support regulatory applications and help inform future approaches to drug repurposing and access to treatments, key areas of interest within PRIME-ROSE.

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