Foreign Data: Sintilimab’s Development Shows What Not To Do When Pursuing US Approval
The FDA’s concerns about conduct of ORIENT-11 trial include adequacy of informed consent, uncertainty about confidence in data generated in China, and failure of development partners Innovent and Eli Lilly to consult the US regulator about the study’s design.
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The Chinese company's R&D leader discusses the US regulatory environment for Chinese-made drugs and implications for the cancer-focused company.
The Chinese company's R&D leader talked to Scrip about the US regulatory environment for Chinese-made drugs and implications for the cancer-focused company.