'Project Orbis' Oncology Pilot Eventually Will Target 'Major Impact' Applications
But US FDA is starting small, OCE Director Pazdur says. Program will hand-select approve high-priority oncology treatments that have to potential to change the standard of care.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Keytruda And FDA’s Oncology Center of Excellence: The Regulatory Milestones Keep Coming
Merck’s anti-PD-1 therapy Keytruda keeps piling up new indications, including three approved by US FDA in just two weeks – all during a pandemic. The remarkable therapy has been a centerpiece for an equally remarkable period of regulatory innovation.
China Unlikely To Be Included In US FDA's Project Orbis In The Near Term
Oncology Center of Excellence Director Pazdur says there must be confidence that confidentiality agreements are universally accepted in response to request that China be included in the multi-regulator application assessment program.