FDA Advisers Say Agency Shouldn’t Approve China-Developed Cancer Drug Now

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FDA Advisers Say Agency Shouldn’t Approve China-Developed Cancer Drug Now
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Experts advising the FDA say Eli Lilly and its Chinese partner should conduct more testing of a lung-cancer therapy developed in China, citing concerns about the testing in China of the drug

A panel advising U.S. drug regulators said Eli Lilly and Co. and its Chinese partner should conduct more studies of a proposed new lung-cancer drug before approval, citing concerns about the medicine’s testing in China.

The advisers voted 14 to 1 on Thursday to recommend the additional testing after Food and Drug Administration officials said a Chinese study of the drug had significant shortcomings and its results weren’t applicable to U.S. patients.

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