Project Orbis Nears 30 Approvals In Oncology; Could China Be Added?

A review of drugs and supplemental uses since the project’s inception shows roughly one-third of the products reviewed have been NMEs.

Confidentiality issues could be slowing US/China regulatory collaborations. • Source: Nielsen Hobbs

China could be a possible addition to the Project Orbis international parallel review initiative within the US FDA’s Oncology Center of Excellence due to high interest from drug sponsors.

However, those plans may be on indefinite hold given the obvious tensions between the two governments over the exchange of

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