US FDA’s Project Orbis Could Streamline Global Clinical Trials In Cancer

 
• By Sue Sutter

Richard Pazdur tells the Pink Sheet that program for concurrent submission of oncology applications and collaborative review by global regulators also could speed approval in smaller countries; first applications under Project Orbis were for use of Lenvima/Keytruda combination for endometrial cancer in US, Canada, and Australia.

FDA's Project Orbis
Project Orbis provides a framework for concurrent submission and review of oncology drugs by FDA and foreign regulators. • Source: US FDA

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