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US FDA’s Foreign Data Policy Faces Its Greatest Test From Chinese PD-1/L1 Inhibitors

 
• By Bridget Silverman

The swift rise of China’s oncology R&D has put at least four novel applications before FDA with pivotal data generated only in China.

Connected network around planet Earth from space for global communication technology concept in Asia as Internet of Things, mobile web, fintech blockc - Image ID: 2ARNH7W (Alamy)
How much of an impact will the country where data originated have on US FDA reviews? • Source: Alamy

At least four novel applications under review at the US Food and Drug Administration rely on clinical trials conducted in China, giving the FDA’s longstanding policy on applications based solely on foreign clinical data what may be its most extensive workout yet.

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