House Republicans attack China-only data in FDA submissions, seek new investigation into research inspections
Three Republican representatives are calling on the FDA to take a closer look at the applications including only clinical data from China.
The letter to FDA commissioner Rob Califf late last week comes as the agency recently rejected Eli Lilly’s anti-PD-1 antibody, which attempted to bring China-only data but ran into a bruising adcomm that may crush the hopes of any other companies looking to bring cheaper follow-ons based only on Chinese data.
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