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Regulatory News
In a 14:1 vote, ODAC nixes a PD-1 drug developed in China; data not generalizable to U.S. population
By Paul Goldberg and Alice Tracey
The FDA Oncologic Drugs Advisory Committee expressed decisive support for the agency’s view that data from trials of checkpoint inhibitors performed in mainland China aren’t applicable to the U.S. population.
White House
By Matthew Bin Han Ong
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