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EMA Will Observe Project Orbis In Effort To Increase Collaboration

 
• By Derrick Gingery

The goal is for EMA officials to better understand the process, but becoming an official member still may prove difficult because of the EMA regulatory scheme.

US and EU gears
The details of the EMA's Project Orbis observer status have not been finalized. • Source: Shutterstock

The European Medicines Agency is not ready to join Project Orbis, the US FDA’s framework for concurrent international review of oncology applications, but will be watching the process more closely as an observer going forward.

The move seems almost anti-climactic given that the EMA and the FDA already work together closely on cancer products. EMA...

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