‘Project Orbis’ Oncology Pilot Eventually Will Target ‘Major Impact’ Applications
‘Project Orbis’ Oncology Pilot Eventually Will Target ‘Major Impact’ Applications
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The US Food and Drug Administration’s Oncology Center of Excellence will hand-select applications to enroll in its “Project Orbis” multi-national parallel review pilot program. Pink Sheet covers how the FDA will focus on applicants that are expected to have a major impact on the standard of care.
Publisher: Pinksheet
- Description
Project Orbis” is a multi-national parallel review pilot program of the United States Food and Drug Administration’s Oncology Center of Excellence (OCE). Richard Pazdur, OCE Director says “Project Orbis” is starting small and hand selecting high-priority oncology treatments that have potential to change the standard of care. Pink Sheet looks at the first Orbis approval that combined two well-known entities that have been approved for several years in multiple indications, what effect the multi-national program is likely to have on the speed of the review process, and how much freedom different countries will still have to approve or not approve therapies.
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