China: Roller Coaster Path To Approval For Eliquis Uncovered By FDA Documents
“It was not publicly revealed at the time, but the FDA documents now show that the reason for the original 3 month extension of the PDUFA date was serious concerns about trial misconduct in China. According to Sutter, a senior clinical site manager, with another monitor, ‘altered source records to cover up evidence of good clinical practice violations.’ This eventually led FDA investigators to question data from 24 of the 36 sites in China.”
