Innovent Biologics Inc and Eli Lilly and Co should be required to conduct a trial of their lung cancer drug that is applicable to the U.S. population, a panel of advisers to the U.S. Food and Drug Administration recommended Thursday.
should be required to conduct a trial of their lung cancer drug that is applicable to the U.S. population, a panel of advisers to the U.S. Food and Drug Administration recommended Thursday.
The FDA in briefing documents released on Tuesday had raised concerns over the lack of a diverse population tested in the study submitted for U.S. approval consideration."Single country submission is a step backward in achieving the racial diversity that we need in the United States," Richard Pazdur, director of the FDA's Oncology Center of Excellence, told the panel.and Roche Holding AG who have made big investments in the hope of benefiting from cheaper trial costs in China.
"We have long-standing initiatives in place to advance diversity and inclusion in Lilly-conducted clinical trials," it said in a statement.
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